FDA Appears To Be Tightening Regulations For Drug Approvals

FDA Appears To Be Tightening Regulations For Drug Approvals

April 15th, 2022 // 1:42 pm @

In a recent endometriosis application for Myfembree by Myovant and Pfizer, FDA included language that is being seen more often, according to pharmaceutical experts.

In the FDA notice, the agency noted deficiencies that prevent discussion of labeling or post-marketing requirements and commitments. This might look like gobbledygook, but some industry analysts are starting to see a pattern.

Analysts at Evercore ISI have noticed that of 14 NDAs where firms got such a notice before the agency’s decision date, more than 50% were in the last 12 months. This suggests that the agency is raising the bar on FDA drug approvals.

Of the 14 notifications that were analyzed, 11 resulted in a complete response letter. But the other three, which included the Myfembree bid by Myovant and Pfizer in endometriosis, have not been resolved.

However, getting a deficiencies letter from FDA doesn’t mean it would eventually be approved. Of the 14 companies that got such a notice, Antares and TherapeuticsMD eventually got drug approvals, and several others have decision dates later this year.

Also attempting to fix deficiencies is Axsome Therapeutics, which got a notice last August on a depression drug. Spero Therapeutics also got a notice from FDA last month on the UTI treatment drug tebipenem.

The letter to Spero was especially notable because it was issued well before the NDA target date in June. Of the other 13 deficiency letters, all but one was within a month of FDA’s decision date. For example, the date for Pfizer and Myovant was May 6.

Provention Bio also got a deficiencies letter, which heard from the agency in April 2021, which was three months ahead of the FDA decision date for the type 1 diabetes drug teplizumab. When the date arrived, the company got a full FDA response letter.

Regarding the other companies still waiting for FDA approval, Evercore analysts think it’s likely they will get approved. Spero’s approval could come next year. The issues that Myovant and Pfizer have should be resolvable because Myfembree has been on the market for some time.

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