6:53 AM
Apr 16, 2018
 |  BC Extra  |  Company News

FDA reverses Alkermes refuse-to-file decision

FDA has accepted for review an NDA for ALKS 5461 from Alkermes plc (NASDAQ:ALKS) as an adjunctive treatment of major depressive disorder, reversing the agency’s decision to refuse to file the application. The decision will not affect the review's timing, Alkermes Chairman and CEO Richard Pops said on a conference call. The PDUFA date is Jan. 31, 2019, and the company expects an advisory committee meeting in 4Q18, Pops said.

Alkermes was up $1.90 to $44.43 on Monday. It has not rebounded from losses sustained April 2, when it lost 22% to $45.23 on news of the refusal-to-file letter.

Pops said the March 30 letter stated that Alkermes had provided insufficient evidence of overall effectiveness, and that it did not provide sufficient bridging data between ALKS 5461 and buprenorphine. ALKS 5461 combines samidorphan (ALKS 33), which is a mu opioid receptor (OPRM1; MOR) antagonist, with buprenorphine (see BioCentury Extra, April 2).

Refusal-to-file letters are typically issued when companies omit essential information in a review application.

FDA withdrew the letter because it agreed with Alkermes that the letter’s statements about the lack of effectiveness data “did not reflect the NDA,” Pops said. It also agreed that the company's bridging data were consistent with the strategy Alkermes had discussed with the agency prior to filing the NDA, Pops said.

Alkermes did not submit additional information or analyses, Pops said.

There is no precedent for FDA rescinding a refusal-to-file decision. Based on the publicly available information, the episode indicates that the agency made a mistake.

The threshold for FDA to accept an NDA is low. A decision to refuse to accept an application is usually based on failure to comply with procedures rather than an application's substance.

Refusal-to-file letters are intended to “help CDER avoid unnecessary review of incomplete applications or certain applications that are submitted as an NDA but should have been submitted as an abbreviated new drug application (ANDA),” according to an FDA guidance document.

The issuance and withdrawal of the letter is unlikely to affect FDA’s review of ALKS 5461, but it could intensify FDA’s scrutiny of the application.

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