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A landmark FDA approval, vexing price hikes, & what it means to waive patents

 

The Readout

Hello, everyone. Damian here with news of yet another use for Eli Lilly's autoimmune treatment, a curious case of rising drug prices, and early promise against a common childhood cancer.

FDA approves first treatment for alopecia

Yesterday, the FDA approved an Eli Lilly arthritis drug as the first treatment for alopecia areata, an autoimmune disorder that leads to sudden and often severe hair loss.

As STAT’s Jonathan Wosen and Akila Muthukumar report, Lilly’s Olumiant helped alopecia patients regrow much of their lost hair in clinical trials. The drug, already approved for rheumatoid arthritis and other autoimmune conditions, works by targeting proteins called JAKs, which play a role in the body’s inflammatory process.

Last year, Lilly brought in $1.1 billion in revenue from Olumiant. Wall Street’s projections for alopecia are more modest, with investment banking firm Muzhou Securities forecasting revenues of $259 million in the U.S. and $154 million in Europe by 2030.

Read more.

Lawmakers want FTC to dig into increasingly pricey drugs

Two influential Democratic lawmakers are asking the Federal Trade Commission to investigate the curious case of two ostensibly competing blood thinners whose prices have increased in lockstep with one another.

As STAT’s Rachel Cohrs reports, Sen. Amy Klobuchar and Rep. Katie Porter wrote to the FTC yesterday calling out what they described as “parallel” price hikes on Xarelto and Eliquis, medicines made by Johnson & Johnson and Bristol Myers Squibb. 

Each medicine has more than doubled in price over the last decade, the lawmakers wrote, “in a manner that seems coordinated to maintain pricing parity.” And that would be illegal under federal antitrust law. 

Read more.

What happens when you waive pharma’s vaccine patents?

That’s the crux of a key debate playing out at the World Trade Organization this week, as a years-long debate over just how to vaccinate the world comes to a head.

As STAT’s Ed Silverman reports, the opposing sides boil down to advocacy groups who argue that pharma’s insistence on enforcing Covid-19 vaccine patents is the major barrier to global access, and industrial representatives who insist that simply waiving patents will have a negligible effect on whether countries in need can get their hands on doses.

Each side has ramped up its pressure campaigns heading into this week’s WTO conference. There’s potential for a compromise, one that might include a temporary waiver limited to a small number of countries. But there’s also a sizable risk that political jockeying, industrial influence, and institutional infighting will derail the entire process.

Read more.

Day One's early data shows promise in childhood cancer

Day One Biopharmaceuticals, a company founded to develop cancer therapies for children, said this week that its most advanced treatment shrank tumors by at least 50% in a majority of kids with the most common form of childhood brain cancer.

As STAT’s Jason Mast reports, the study enrolled 22 patients ages 3 to 18 with low-grade glioma who had progressed on at least three previous treatments and gave them Day One’s tovorafenib. Of those patients, 14 — or 64% — saw their tumors wither to less than half their original size. Six others had stable disease.

The data are the first results from a larger, 60-patient trial that will read out in the winter and potentially support an FDA submission. For Day One, which opened its doors in 2020, the early success is an affirmation of its business model. “I told everybody, when we started this company — I said, if we make just one kid better, it will all have been worth it,” co-founder and Chief Medical Officer Sam Blackman said.

Read more.

More reads

  • Francis Collins on his new life as White House science adviser. STAT
  • Moderna’s Covid vaccine is effective in children under 6, FDA says. New York Times
  • FDA approved more cancer drugs than EMA, but they may not have always benefited patients. STAT
  • GSK castoff starts life with target on its back. Reuters

Thanks for reading! Until tomorrow,

@damiangarde
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Tuesday, June 14, 2022

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