FDA to make decisions on several drug applications in July (NASDAQ:BIIB)

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Headquarters of US Food and Drug Administration (FDA) — Grandbrothers

Several drugmakers are eagerly awaiting application decisions from the FDA in July.

The most significant decision comes on July 6, when Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) will find out if the agency will convert accelerated approval for their Alzheimer’s therapy Leqembi (lecanemab) to traditional approval.

If the FDA chooses to do so, it is a significant development for the company as it would likely lead to Medicare coverage of the biologic therapy. In June, an FDA advisory panel recommended full approval of Leqembi.

The next action date is July 23 for Verrica Pharmaceuticals’ (NASDAQ:VRCA) VP-102 for the treatment of the skin disease molluscum contagiosum.

The FDA declined to approve the company’s New Drug Application in March 2022 citing deficiencies at a contract manufacturing organization facility. The application was resubmitted in January.

Finally, on July 28, the FDA will act on Citius Pharmaceuticals’ (NASDAQ:CTXR) Biologics License Application for Lymphir, a purified reformulation of Ontak (denileukin diftitox) for cutaneous T-cell lymphoma, a rare form of non-Hodgkins lymphoma.