FDA advisors endorse Leqembi

FDA advisors voted unanimously on Friday to recommend traditional approval for Leqembi—here’s what happened and the next steps. Plus, while you were convention-ing, there was talk around the world about IP waivers. (671 words, 3 minutes, 20 seconds)

FDA advisors endorse Leqembi

It’s a step towards traditional approval for the groundbreaking Alzheimer’s drug. 

The news: Food and Drug Administration (FDA) advisors voted unanimously Friday to recommend traditional approval for Leqembi, the Alzheimer’s drug developed by Eisai and Biogen. The drug was granted accelerated approval in January.

Why it matters: Leqembi would be the first in a new class of Alzheimer’s drugs to receive traditional approval. In the confirmatory Phase 3 trial, the drug demonstrated “a highly statistically significant slowing of cognitive and functional decline (27%, p=0.00005) compared to placebo over 18 months,” says Eisai.

The problem: Centers for Medicare and Medicaid Services (CMS) recently confirmed Medicare would only cover drugs in this class if they receive traditional approval and patients participate in a registry, which the Alzheimer’s Association called an “unnecessary and potentially harmful barrier.”

What they’re saying: “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks. Now all eyes turn to CMS,” said Alzheimer’s Association President and CEO Joanne Pike, DrPH. “Medicare is supposed to be a rock-solid guarantee for Americans, and it is time for CMS to step up and provide Medicare access on the day of an FDA traditional approval.”

The next steps: The FDA is expected to decide on traditional approval by July 6. The FDA advisory committee decision is non-binding, but typically, the FDA follows advisory committee decisions.  

Strong IP enables COVID technology sharing; IP waivers don’t

While you were convention-ing, an international meeting and House hearing explored how strong IP protections—not IP waivers—can help us share biotech and tackle the next pandemic.

Technology sharing, by the numbers: 44 approved therapeutics and 59 approved vaccines were shared through 177 collaborative agreements for production and commercialization, says an Airfinity report presented at a conference organized by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Here’s how: Sharing technology requires finding partners with adequate quality standards, workforce, and technical ability; flexible approaches to enable optimum use of resources; and strong IP protections that enable trust, conference participants agreed.

No government has utilized the waiver of COVID vaccine IP—which, as the numbers show, was not needed to distribute vaccines yet still harmed innovation by weakening IP protections, said participants in last week’s House Judiciary hearing.

According to written testimony from BIO: “The global IP framework has enabled this lifesaving innovation and provides a reliable legal foundation for companies to voluntarily license their IP to enhance research collaborations and provide timely, equitable global access to safe and effective therapeutics.”

This is why waivers don’t work. Waiving IP protections was the wrong approach to sharing COVID-19 vaccines, and plans to extend the waiver to COVID-19 therapeutics and diagnostics will also fail while putting innovation at risk.

Read full coverage of the conference and hearing in Bio.News.

More News: 

Biopharma Dive: Medicare sets next tranche of drugs to face price hike penalties
“The Biden administration on Friday said it will levy penalties on the manufacturers of 43 prescription drugs for increasing prices within Medicare faster than inflation, flexing new powers granted to it under last year’s Inflation Reduction Act… The new list is larger than an initial slate of 20 published in March for last quarter, the first period in which the Centers for Medicare and Medicaid Services could lower coinsurance as a result of the law.” 

Reuters: U.S. Chamber of Commerce sues over government’s drug pricing power
“In a complaint filed in federal court in Dayton, Ohio, the chamber said the pricing program violated drugmakers’ due process rights under the U.S. Constitution by giving the government “unfettered discretion” to dictate maximum prices.”

President Biden’s Monday: Hosting College Athlete Day at the White House, where he’ll honor women’s and men’s NCAA Champion teams from the 2022-2023 season. Then, meeting with Jens Stoltenberg, Secretary General of the North Atlantic Treaty Organization (NATO), to discuss the NATO Summit in July.

What’s Happening on Capitol Hill:Health and Human Services (HHS) Secretary Xavier Becerra and outgoing CDC Director Dr. Rochelle Walensky will testify during separate hearings in the House on Tuesday. Also on Tuesday, BIO's SVP, Infectious Disease and Emerging Science Policy, Phyllis Arthur, will testify before the House Health Subcommittee on “Legislative Solutions to Bolster Preparedness and Response for All Hazards and Public Health Security Threats”