Alzheimer’s drug gets FDA panel’s backing, setting the stage for broader use

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. (REUTERS)
The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. (REUTERS)
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Updated 11 June 2023
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Alzheimer’s drug gets FDA panel’s backing, setting the stage for broader use

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. (REUTERS)
  • The FDA panel reviewed more recent data from an 1,800-patient study in which people taking the drug showed a modestly slower rate of decline on measures of memory, judgment and other cognitive tests

WASHINGTON: Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer’s drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease.
The drug, Leqembi, received conditional approval from the Food and Drug Administration in January based on early results suggesting it could slow Alzheimer's progression by several months. The FDA now is reviewing more definitive results to decide whether the drug should receive the agency’s full endorsement.
The decision carries extra significance because insurers have held off on paying for the infused treatment until it has full FDA approval.
The FDA panel of outside advisers voted 6-0 that a large company study confirmed the drug's benefits for patients with mild or early Alzheimer's. The nonbinding vote amounts to a recommendation for full approval, and the FDA is scheduled to issue a final decision on the matter by July 6.
The FDA’s initial OK for Leqembi came via the agency’s accelerated approval program, which allows early access to drugs based on laboratory or biological measures suggesting that they might help patients. The drug, marketed by Eisai and Biogen, helped clear a brain plaque that is a hallmark of Alzheimer’s.
The FDA panel reviewed more recent data from an 1,800-patient study in which people taking the drug showed a modestly slower rate of decline on measures of memory, judgment and other cognitive tests.
“For an illness like this where we don’t have very much, these are meaningful changes for patients with Alzheimer’s,” said Dr. Merit Cudkowicz of Harvard Medical School. “A couple more months in the highly functional state is really meaningful.”
Drugs approved via the accelerated pathway can technically be withdrawn by the FDA if their benefits aren't confirmed, though regulators rarely take that step. Gaining full approval allows medications to stay on the market indefinitely.
Normally the process of converting an accelerated approval attracts little attention, and FDA rarely convenes its advisers to weigh in on such decisions.
But concerns about the cost and effectiveness of new plaque-targeting drugs like Leqembi have attracted new scrutiny to the process from academics, members of Congress and health insurers.
Medicare, the federal health plan that covers 60 million seniors, has essentially blocked coverage of Leqembi and a similar drug, Aduhelm, pending full FDA approval. That policy, which has little precedent, was announced last year amid concerns that Aduhelm, priced at $28,000-a-year, would drive up costs for Medicare recipients.
The federal program provides health insurance for the vast majority of people with Alzheimer’s, and private insurers tend to follow its lead.
Leqembi is priced similarly at $26,500 per year and the handful of patients who have received it to date have mainly had to pay out of pocket.
Facing pressure from Alzheimer’s advocates and patients, Medicare’s administrator, Chiquita Brooks-LaSure, has made clear the program will immediately begin covering the drug if it gets FDA’s full OK.
But last week she announced extra requirements even after Medicare coverage begins: All patients receiving the drug will need to be enrolled in a federal registry to track Leqembi's safety and effectiveness. That approach is occasionally used for complex new medical devices, but rarely for drugs.
The move was criticized by advocacy groups, including the Alzheimer’s Association, which has lobbied the federal government for months to begin paying a drug that they say could potentially help many thousands of Americans.
Leqembi is the first drug that’s been convincingly shown to slow Alzheimer’s by targeting the underlying biology of the disease. The delay in progression amounts to about five months, and some experts disagree on whether that difference is enough to meaningfully improve people's lives.
But most FDA panelists were impressed by Eisai's results, which they said showed significant differences in patients' cognitive abilities and functionality, as well as reduced burden for caregivers.
The study tracked patients for 18 months using a scale measuring key indicators of cognitive function. At the end of the trial, patients receiving Leqembi declined more slowly — a difference of less than half a point on the scale — than patients who received a dummy infusion.
The drug was also associated with potentially serious side effects, including swelling of the brain and small bleeds in brain vessels.
Three patients taking Leqembi died during the study, two after experiencing a stroke linked to brain bleeding. But FDA reviewers said it was unclear whether the drug played a role in the deaths due to other underlying factors affecting the patients, including the use of blood-thinning medications that can increase the risk of bleeding.
“There are adverse effects,” said Dr. Robert Alexander of the University of Arizona, who chaired the panel. “But they're monitorable and I think the benefit is clear.”

 


Review: Bylsan, locally made herbal feminine hygiene products

Review: Bylsan, locally made herbal feminine hygiene products
Updated 5 min 15 sec ago
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Review: Bylsan, locally made herbal feminine hygiene products

Review: Bylsan, locally made herbal feminine hygiene products

If you are looking for a vaginal wash that is gentle, safe, potentially healing and locally made, try Bylsan. Formulated by former King Fahd Medical City researcher and gynecologist-turned-entrepreneur, Dr. Ahmed Al-Badr, the product has been approved by the Saudi Food and Drug Authority.

Made with myrrh and lavender extracts, the 200 ml bottle has clear liquid inside that lathers nicely without feeling heavy or sticky. The product is free of sulfates, silicone, parabens, and artificial fragrances.

Acting as an acidity neutralizer, the wash is suitable for daily use. Its main aim is to help cleanse the sensitive area and reduce the risk of infection. It is safe for new mothers to use post-surgery and promises to help relieve delivery pains.

Al-Badr told Arab News: “Leveraging my background in research and gynecology, I meticulously formulated Bylsan wash with a deep understanding of women’s intimate health needs.”

“Knowing the lack of such products and through scientific investigation and clinical expertise, I ensured that Bylsan not only meets the highest standards of safety but also addresses specific gynecological concerns effectively.”

Al-Badr is committed to creating a line of products to advance “women’s well-being, combined with a strong research foundation,” and said he has 15 new products in the pipeline. His only hurdle, so far, has been securing funding.

Available at Whites for SR90 ($24), the price tag is a bit steep compared to similar imported offerings on the shelves, but it is well worth a try.

With a vibrant presence on social media, Al-Badr has become a pioneer in normalizing conversations about women’s body health and creating products to support them in the Kingdom.

For more information, check out their Instagram @bylsanksa.


Where We Are Going Today: Roll and More

Where We Are Going Today: Roll and More
Updated 30 September 2023
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Where We Are Going Today: Roll and More

Where We Are Going Today: Roll and More

JEDDAH: Roll and More serves up Indian street food in a fine dining setting with modern decor. Located in Jeddah’s Hira Street, the restaurant’s ambience is cozy and comfortable. While I anticipated an all-Indian musical playlist, the eclectic soundtrack added a unique touch to the dining experience.

For my appetizers, I selected the fried samosas, which were generously stuffed with spiced potato and served with two sauces: a zesty chili mint yogurt and a sweet, tangy tamarind sauce. I also ordered the butter shrimp tacos, which came drenched in a rich sauce infused with Indian spices.

My main course was flavorful biryani rice infused with an aromatic blend of nuts and Indian spices paired with the chicken butter masala — a tender and mouthwatering delight — accompanied by two slices of buttery naan bread. 

I also indulged in the grilled shrimp roll — a generously sized tortilla loaded with tomatoes, lettuce, and some special Indian sauce to complement the shrimps.

To quench my thirst, I could not resist the fresh mango lassi. This refreshing beverage provided a welcome respite from the spices, though its thick and creamy texture might prompt you to order a glass of water.

The dessert — caramel French toast served with a scoop of vanilla ice cream — was a true delight and stole the spotlight from the rest of the meal. The contrasting textures and flavors created a delightful symphony for the taste buds. 

Roll and More also offers an array of options for group dining, including rice bowls, roll boxes, and taco boxes, making it a perfect choice for gatherings and parties.

The friendly and efficient staff further enhanced the overall experience.

For more information, visit @rollandmoreksa on Instagram.


Recipes for success: Chef Steven Gibbs offers advice and a delicious seafood recipe

Recipes for success: Chef Steven Gibbs offers advice and a delicious seafood recipe
Updated 29 September 2023
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Recipes for success: Chef Steven Gibbs offers advice and a delicious seafood recipe

Recipes for success: Chef Steven Gibbs offers advice and a delicious seafood recipe

DUBAI: Chef Steven Gibbs likes to laugh. Throughout our interview, Gibbs — the executive chef of Scott’s Riyadh — jokes and smiles. But underneath the jovial exterior is a serious mind focused on serving a great experience to customers.   

He also likes crab, which makes him an ideal fit to head the Riyadh branch of Scott’s, the hugely successful London-based seafood restaurant.  

Caption

Gibbs began his career at another London hotspot: the legendary theatre eatery The Ivy, under the restauranter Des McDonald, and has worked at several other high-profile eateries, including Gordon Ramsey’s Verre in Dubai, London’s Soho House, and event production and catering company Urban Caprice, before his move to Riyadh.   

Here, Gibbs talks co-cooking, mellowing with age, and burning toast.    

Q: What’s your top tip for amateur chefs?    

A: If you’re cooking at home, for a dinner party, for instance, I’d advise asking someone to do it with you. It makes it a more enjoyable experience. And if I was cooking for three or four people, I’d definitely want someone helping me.   

What was the most common mistake you made when you were starting out?  

I think most chefs burn toast a lot. (Laughs.) It’s very common during service. When I worked at The Ivy, we used to have eggs Benedict on the menu and I used to burn the English muffins all the time; I’d put them on the grill and just forget them.   

Salmon. (Supplied)

What one ingredient can instantly improve any dish?  

I’m going to go back to when my dad used to cook. He was a terrible cook; he was so bad that I developed a phobia about mashed potatoes — I couldn’t eat them until I started working in restaurants. So, salt and butter. That’s all I can say.  

What’s the most common issue you find in other restaurants when you go out to eat?    

Sometimes, I think people try too hard. Like, if the server is a little shy or unsure, it adds a bit of humanity to the experience. I never criticize — I don’t do reviews; I prefer a casual approach.  

When you go out to eat, what’s your favorite cuisine/dish to order? And why?  

I don’t have a favorite cuisine – I like all food. But my favorite ingredient is crab, so I’ll say anything with fresh crab and peanuts.  

What’s your go-to dish if you have to cook something quickly at home?  

I’m getting old so I’m trying to stay in shape and not have carbs. Usually, my go-to dish is a cheese omelet with a fresh tomato salad. You can’t beat that.  

Yellowtail carpaccio. (Supplied)

 What customer behavior most annoys you?  

Honestly, people are people. Everyone has different tastes. I think because I’m getting old, I’m never shocked and I don’t get annoyed.   

  What’s your favorite dish to cook and why?   

I’m from the UK, where it can get quite cold. So I like slow cooking meats, like lamb shoulder or beef cheek or short rib. It takes a lot of skill, a lot of precision, and, when it comes out right, it’s really satisfying.  

  What’s the most difficult dish for you to get right (whether on your current menu or not)?  

Probably pastry — cakes, meringues, eclairs... I can do some, but it’s the most difficult thing to get right because it takes more time, more precision… the weight needs to be right, the oven… there are a lot of things that need to come together.   

As a head chef, what are you like? Do you shout a lot? Or are you more laid back?  

I don’t remember ever losing someone from a kitchen because of me. I think I’m laid back. I never shout at people, but I do like people to be honest in the kitchen.   

(Supplied)

Chef Steven’s prawns with chilli jam, apple and green papaya salsa 

INGREDIENTS (serves four): 

For the jam: 1 tblsp corn oil; 1 red onion, roughly chopped; 70g fresh ginger, peeled and roughly chopped; 60g fresh red chili, roughly chopped; 10g dried red chili or chili flakes; 60g garlic, peeled and crushed; 90g caster or granulated sugar; 40g brown sugar; 400g fresh or tinned tomatoes, blended; 100ml rice wine vinegar; 40ml fish sauce 

For the salsa: 1 green apple, core removed and finely chopped; ½ green papaya, green mango or firm orange mango, peeled and finely chopped; 1 long red chili, deseeded, finely chopped; 50g spring onion, finely chopped; 20ml mirin; 20ml rice vinegar; 40ml olive oil 

For the prawns: 100ml corn oil; 16 good size prawns, peeled and de-veined (just the mid-section, or the head and tail if preferred); 80g butter, diced; 2 garlic cloves, peeled and roughly chopped; a handful of washed, chopped fresh parsley 

INSTRUCTIONS:  

For the jam: Lightly heat the corn oil in a heavy-based saucepan. Add the onion, ginger, garlic, and chilies, and cook on a low heat (the ingredients should not change color) for five minutes. Add the rest of the ingredients and allow to simmer for about 45 minutes, until the jam is thick and glossy. Remove from the heat, allow to cool for about 15 minutes, then blend to a smooth consistency in a food processor. Leave in the fridge until required. 

 For the salsa: Mix all the ingredients together. Season with salt and freshly ground white pepper and leave to stand until needed. 

For the prawns: Heat a skillet or frying pan. Add the prawns four at a time and cook for one minute on each side, then move to a flat baking sheet. Repeat until all the prawns are cooked. In the same skillet or pan, add the butter and garlic and cook until the butter is bubbling. Add the chopped parsley and a squeeze of lemon and pour over the prawns. Spread some chili jam on to the plates, add the prawns and finish with the apple and papaya salsa.  


Saudi Arabia’s senior citizens on a mission to promote exercise, hiking

Saudi Arabia’s senior citizens on a mission to promote exercise, hiking
Updated 24 September 2023
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Saudi Arabia’s senior citizens on a mission to promote exercise, hiking

Saudi Arabia’s senior citizens on a mission to promote exercise, hiking
  • Abdulrahman Al-Bani, a team member, told Arab News: “The Southern Travelers Team was established on the 88th Saudi National Day. At that time, we walked from Baljurashi to Abha in southern Saudi Arabia”

MAKKAH: A group of elderly Saudi travelers is touring the globe to promote sports and the idea that everyone should participate in them on a regular basis to prevent diseases.

The experienced hikers range in age from 61 to 79 years old, and practice their activities year-round, most notably on public holidays. They have scaled numerous summits throughout the world.

They believe that one must exercise regularly, especially hiking, to strengthen the heart and promote good health.

Abdulrahman Al-Bani, one of the founding members of the Southern Travelers Long Distance Team, told Arab News: “The Southern Travelers Team was established on the 88th Saudi National Day. At that time, we walked from Baljurashi to Abha in southern Saudi Arabia.”

He added that on the 89th National Day the group walked a long distance from Abha to Baha and from Baha to Abha the next year. They walked from Abha to Dhahran Al-Janoub on the 91st National Day.

“On National Day 92, we made a trip along a path we called ‘Qyam and Shamam,’ which is a path similar to some European countries. It was 242 km long and passed through ancient villages, museums, and tourist attractions such as parks, mountains and valleys in the beautiful Asir region.”

The team has also started commemorating the Kingdom’s Founding Day with walking trips. Al-Bani explained: “Two years ago, on Founding Day, we walked from Baha Province to Makkah Province, passing through the migration trail from Makkah to Madinah. We made another trip from the Jazan Governorate in southern Saudi Arabia to the last governorate in Baha Province, a distance of 420 km.”

He explained that the team tours all regions and governorates of the Kingdom, holds events and encourages practicing sports through setting an example. It currently consists of 10 members.

One of the valuable aspects of their excursions has been developing a community and getting to know each other. “We got to know each other in walking and hiking activities. The team came together and became harmonious and consistent with each other. We carry a national and societal message to citizens and residents of Saudi Arabia,” Al-Bani added.

He pointed out that the Ministry of Health spends billions to treat diseases such as narrowed arteries, heart disease, diabetes, and cholesterol. These huge amounts of money could be saved if people walk for at least half an hour a day.

“We aspire to be a good role model for young people and the elderly when we walk in cities, parks, and villages,” Al-Bani said, noting that team members “do not suffer from any diseases, not even diabetes or high blood pressure, thanks to the continuous physical effort that they are always keen to do, despite the fact that most of the team members are close to 80 years of age.”

Al-Bani added: “This week, in just one day, the team covered a distance of 21 km in Al-Soudah Mountains, which rise 2,400 meters above sea level. We have extensive experience in walking and hiking. We have become professional, but our message to everyone is do not exhaust yourself. Just exercise regularly.”

He noted that the group had trekked summits such as “the Himalayas, Everest, Kilimanjaro, Tanzania, Africa, and the Elbrus Mountains, which are the highest peaks in Europe and Russia.”

He added: “We walked on the Mont Blanc Trail in France, Italy, Switzerland, and the Western Highlands as well in Scotland. The group also climbed the highest peak in the Arab world in the Atlas Mountains in Morocco — Toubkal.”

 


Where We Are Going Today: ‘Aleppo’ a Syrian restaurant in Riyadh

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Photo/Supplied
Updated 24 September 2023
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Where We Are Going Today: ‘Aleppo’ a Syrian restaurant in Riyadh

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  • Customers will enjoy a variety of flavors on Aleppo’s menu including shishbarak, yabriq, and farika, which are all popular Syrian dishes

Aleppo is a Syrian restaurant located on Prince Mamdouh Bin Abdulaziz Street in Riyadh. This eatery provides a selection of authentic Syrian dishes but with an interesting twist on some of the original recipes.

Aleppo’s historic interiors, ambiance, musical playlist, and paintings by notable Syrian artists hanging on the walls all transport guests to the city of Aleppo, with its historic buildings and ancient passageways. The restaurant has created the perfect recipe for a great time with family and friends, while also satiating the appetite with delectable food.

Customers will enjoy a variety of flavors on Aleppo’s menu including shishbarak, yabriq, and farika, which are all popular Syrian dishes. If you are a fan of kebabs, you will find a variety to choose from, including kabab halabi, popular among regulars, and kabab tahinah, which is mixed with tahina sauce and other spices. Other appetizers on the menu are hummus, tabouleh, and kubbah.

One of their best items is dolma with meat, a specialty in Aleppo. It is cooked with meat unlike the usual way of making dolma where many cook it with olive oil.

The place is a bit small and finding a parking space can be challenging especially early in the evening and during peak hours. Thus, it is recommended to avoid going to the restaurant during those times to save yourself some time, and visit during lunch hours or for a late dinner.

The restaurant opens every day from 12 p.m. until 1 a.m., except on Thursdays and Fridays where they extend the time for one more hour.