FDA approves Wegovy to reduce cardiovascular risks; delays action on Lilly’s Alzheimer’s drug

By PharmaCompass

2024-03-14

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In this week’s news, Novo Nordisk’s Wegovy became the first obesity drug cleared by the US Food and Drug Administration (FDA) to lower the risk of cardiovascular death, heart attack, and stroke.

There was a fair bit of unfortunate news for patients with neurological disorders. First, FDA delayed the approval of Eli Lilly’s donanemab for Alzheimer’s and called for further scrutiny of its safety and efficacy. Second, Amylyx Pharmaceuticals’ lead candidate Relyvrio bombed in a large, phase 3 clinical trial for amyotrophic lateral sclerosis (ALS), raising questions about its future.

The Biotechnology Innovation Organization (BIO), an industry trade group based in Washington, is taking steps to remove China’s WuXi-AppTec from its membership. The staff at FDA has raised doubts over the benefit of giving Johnson & Johnson and Bristol Myers Squibb’s cell therapies, Carvykti and Abecma, to blood cancer patients as an early treatment.

Serum Institute of India, which teamed up with AstraZeneca to produce the Covishield vaccine, has repurposed its manufacturing facilities for newer vaccines against malaria and dengue. And, India’s Sun Pharma was forced to recall 55,000 bottles of the gout drug febuxostat from the US market due to microbial contamination in stagnant water in the duct of the manufacturing equipment.

Wegovy approved in US to lower risk of serious heart problems in obese adults

FDA has approved Wegovy (semaglutide) to reduce the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease. The move makes Wegovy the first weight loss medication that is also approved to help prevent life-threatening cardiovascular events and is hailed as a major advance for public health. In a trial spanning 17,604 patients, over a mean duration of 33 months, Wegovy lowered the risk of non-fatal heart attack by 28 percent, heart-related death by 15 percent, and non-fatal stroke by seven percent.

FDA delays action on Lilly’s closely watched Alzheimer’s drug donanemab

The much anticipated approval of Eli Lilly’s donanemab scheduled for this month has been deferred as FDA has opted to convene a panel of independent experts to assess the drug’s safety and efficacy. The decision took Alzheimer’s experts and Lilly by surprise as the latter said, “it is unusual for an advisory committee to occur after the anticipated FDA action date.” The decision underscores the high stakes and challenging history of developing Alzheimer’s treatments.

According to a Lilly press statement, FDA is likely to convene a meeting of its advisory committee that looks into peripheral and central nervous system drugs to discuss its trial that evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer’s disease.

Roche’s persistence for Alzheimer’s therapy sees promising results: After two failures to bring an Alzheimer’s drug to the market, Roche touted “best-in-class potential” for trontinemab in treating the disease. Though the antibody is still in early phase 2 trials, Roche came out with promising data that showed trontinemab cleared clumps of amyloid protein from patients’ brains faster than Leqembi and donanemab. Trontinemab’s delivery uses the Swiss pharma’s proprietary “Brainshuttle” platform which allows it to penetrate the blood-brain barrier resulting in more exposure to the brain and broader distribution across the central nervous system.

Biotech trade group severs ties with China’s WuXi AppTec over security concerns

The Biotechnology Innovation Organization (BIO), an industry trade group based in Washington, said it is taking steps to remove China’s WuXi-AppTec from its membership. BIO’s new CEO, a former Naval Intelligence Officer, said it was part of “several important steps to reaffirm the organization’s position with regards to national security.” Last week, the Senate’s homeland security committee voted to pass a bill that prohibits federal agencies from having contracts with four Chinese biotechs, including WuXi AppTec.

Amylyx’s ALS drug Relyvrio flunks late-stage trial, could get pulled from market

Just under two years ago, Relyvrio (sodium phenylbutyrate and taurursodiol) became one of only three treatments approved by the FDA for ALS, commonly called Lou Gehrig's disease. The agency had done so on the back of results from a phase 2 trial. The debilitating condition robs patients of the ability to walk, talk, and eventually breathe within five years. Now, the results of a 48-week trial in 664 patients are in, and Relyvrio failed to demonstrate that it worked better than a placebo.

“We’re deeply saddened, and I’d say it’s been a really, really tough day for the ALS community,” Amylyx Co-CEO Justin Klee said. The Cambridge, Massachusetts-based biotech said it might withdraw Relyvrio from the market and will announce its plans within eight weeks.

Acadia to stop trials for its antipsychotic drug: Acadia Pharmaceuticals’ antipsychotic drug Nuplazid (pimavanserin) failed to meaningfully improve negative symptoms of schizophrenia in a phase 3 trial. Those symptoms included “blunted affect, poor socialization, and lack of motivation.” Nuplazid was the first FDA-approved drug to treat psychosis-related delusions and hallucinations experienced by certain patients with Parkinson’s disease. However, previous attempts to expand the drug’s use to treat dementia and Alzheimer’s disease had also resulted in failure.

SII shifts focus to malaria, dengue vaccines: Adar Poonawalla, CEO of Serum Institute of India (SII), has said his company has bolstered its manufacturing capabilities ahead of launches of shots against dengue and malaria planned over the next few years. During the pandemic, SII had invested US$ 2 billion to boost production. Now, with the demand for Covid-19 products waning, the world’s largest vaccine maker has repurposed its facilities for newer shots.

FDA tells Sun Pharma to recall 55,000 bottles of gout med due to contamination

The New Jersey unit of Indian drugmaker Sun Pharma is recalling 55,000 bottles of generic gout treatment Febuxostat, according to FDA’s enforcement report. Deviations from current good manufacturing practices (cGMPs) have caused microbial contamination in stagnant water in the duct of the manufacturing equipment. The lots in question were made in Dadra (India) for Memphis-based Northstar Rx LLC.

Carvykti, Abecma may not benefit patients with early-stage blood cancer

The staff at FDA has raised doubts over the benefits of giving J&J and Bristol Myers Squibb’s cell therapies, Carvykti and Abecma, to blood cancer patients as an early treatment. Both are chimeric antigen receptor (CAR) T-cell therapies. An FDA advisory committee will vote Friday on whether the two therapies have a favorable benefit-risk ratio in earlier lines of multiple myeloma treatment.

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