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Thursday, May 26, 2022

Amgen’s Otezla May Be Approved for Broader Use

Amgen Inc. on Wednesday said its psoriasis drug Otezla was approved for review by the Food and Drug Administration to be used on a wider patient population.Originally, the much-advertised drug could only be prescribed for those with moderate to severe plaque psoriasis. Now that scope may broaden to include patients with mild to moderate cases of the skin disease, the Thousand Oaks biotech said.FDA approval review is based on data submitted Feb. 19 from a Phase 3 clinical trial, where participants saw a 75 percent improvement in skin condition, at the least. The FDA has until Dec. 19 to make a decision on the drug's potential use.Dr. David Reese, vice president of research and development at Amgen, said in a statement that Otezla has been prescribed to hundreds of thousands with moderate-to-severe plaque psoriasis, but “we believe it could play an important role in addressing the unmet need for adults affected by mild-to-moderate plaque psoriasis who have had challenges managing their disease with existing topical therapies alone.”Amgen paid Celgene Corp. a whopping $13.4 billion to buy Otezla in August 2019. The coveted drug is the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, the biotech giant said, and was even tested as a possible anti-inflammatory treatment for COVID-19 patients with acute respiratory distress syndrome.Shares of Amgen (AMGN) closed up $1.99, or less than one percent, to $249.35 on the Nasdaq on Wednesday, a day when that exchange closed down a fraction of a percent.

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