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FDA gives Amgen priority review for asthma treatment

By   /   Friday, July 9th, 2021  /   Comments Off on FDA gives Amgen priority review for asthma treatment

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Thousand Oaks-based Amgen received a priority review for tezepelumab, a treatment for asthma, from the U.S. Food and Drug Administration, the biotech giant announced July 7.

According to Amgen, tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population of clients in phase 2 and 3 trials.

Patients with severe asthma do not always qualify for or respond well to current medicines on the market and patients with severe, uncontrolled asthma experience frequent exacerbations, significant limitations on lung function and a reduced quality of life, Amgen said.

“We are proud to advance an innovative, first-in-class monoclonal antibody that targets the top of the inflammatory cascade and represents a potentially transformative treatment option for a broad population of patients with severe asthma,” Dr. David Reese, executive vice president of research and development at Amgen, said in the company’s news release. “We look forward to bringing tezepelumab to patients as quickly as possible.” 

The FDA grants priority review to applications for medicines that offer significant advantages over available options by highlighting safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.

Under the Prescription Drug User Fee Act, the goal date for a decision by the FDA on Amgen’s new drug is during the first quarter of 2022.

Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. According to a press release, AstraZeneca leads development while Amgen leads manufacturing. Both companies will share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. 

Under an amended agreement signed in 2020, in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab as Amgen will record sales in the U.S. and AstraZeneca will record sales in Canada. Outside the U.S., Amgen will record sales as collaboration revenue.

Amgen shares were unaffected by the news on July 7, closing at $243.22, just a few cents above their opening price. Shares opened at $243.09 on July 9 and were up 0.4% late in the trading day.

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