Amgen asks FDA to approve key asthma drug

Dive brief:

  • Amgen said on Monday that it had submitted its asthma drug tezepelumab for approval to the Food and Drug Administration, promising a drug that is critically important to its plans to grow beyond Aging blockbusters that have supported his business for years.
  • Tezepelumab, which Amgen has been developing with its partner AstraZeneca for nearly a decade, is a biologic drug that works to reduce inflammation in the airways in a new way. By blocking a protein known as TSLP, tezepelumab is believed to prevent the release of other pro-inflammatory proteins, thereby reducing asthma attacks.
  • The results of a study called NAVIGATOR, published in November, confirmed this hypothesis, showing that treatment with the drug reduced seizures in patients with severe asthma. But data from a much smaller clinical trial a month later raised questions about the competitiveness of tezepelumab.

Dive overview:

Amgen’s submission to the FDA is on schedule and, if the agency accepts the company’s request, could put an approval decision in place probably early next year.

Amgen is seeking approval for the use of tezepelumab in a large population of people with severe asthma. The company estimates that there are approximately 2.5 million patients worldwide whose condition is not properly controlled or who are eligible for biologic drug therapy. About 1 million are in the United States, according to the company.

In the NAVIGATOR study, adding tezepelumab to standard-care medications reduced the annualized rate of asthma attacks by 56%. Among patients with lower levels of eosinophils, a type of white blood cell more common in people with severe asthma, the reduction was 41%.

But in the other, smaller trial, called SOURCE, treatment with tezepelumab failed to help reduce the daily dose of corticosteroids needed by patients with asthma – a finding Amgen R&D director David Reese said. , described as “surprising”.

If approved, tezepelumab would compete with Sanofi and Regeneron’s best-selling drug, Dupixent, among others. Previous tests have shown that treatment with Dupixent reduces the use of steroids.

Amgen will present further data on tezepelumab at the American Thoracic Society International Conference later this month.

“W“We think the clinical profile of this molecule is quite attractive,” Amgen CEO Robert Bradway said in a recent conference call with analysts. “My opinion continues to be that this will just be a very important asthma drug for patients.

It is also a very important drug for Amgen’s business, as sales of once top-selling drugs like Enbrel and Neulasta plummet. Overall, drug sales declined 5% year-over-year during the months of January through March, although the company attributed some of the declines to the impact of COVID-19 and lowered prices.

As several products, such as the cholesterol drug Repatha, develop, Amgen relies on tezepelumab and a closely watched cancer drug called Lumakras to boost its business going forward. An FDA decision on Lumakras, which would be the first drug against cancers pushed to grow by mutations in a gene called KRAS, is expected by August.

Investors are also watching another cancer treatment called bemarituzumab, which Amgen acquired through a $ 1.9 billion buyout from biotech Five Prime Therapeutics in March.


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