Just months after the controversial FDA approval of Alzheimer’s disease drug Aduhelm (aducanumab), partners on that medicine, Eisai Co. Ltd. and Biogen Inc., are advancing a BLA for a new AD candidate, lecanemab. Formerly known as BAN-2401, the Bioarctic AB-originated antibody is designed to neutralize and eliminate soluble, toxic amyloid beta for the treatment of early AD. The rolling BLA, submitted under the accelerated approval pathway, is primarily based on clinical, biomarker and safety data from a phase IIb trial in people with early AD and confirmed amyloid pathology.

Union Therapeutics strikes deal with Innovent to develop Otezla challenger in China

Denmark’s Union Therapeutics A/S has begun a strategic collaboration with Innovent Biologics, Inc., over orismilast, a next-generation oral PDE4 inhibitor for inflammatory dermatology conditions that could compete directly with Amgen Inc.’s psoriasis blockbuster Otezla (apremilast). At the same time the company is looking for partners in the medium term to develop the drug in the rest of the world as it bids to take on Amgen and other dermatology players such as Bristol-Myers Squibb Co.

Pfizer-Biontech says official EUA request for vaccinating children against COVID-19 is near

Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, are falling behind. Pfizer-Biontech said they plan to make a formal EUA request for the vaccine’s use in children “in the coming weeks.” Pfizer-Biontech’s vaccine is FDA-authorized for those ages 12 through 15 and fully approved for those ages 16 and older. Moderna has yet to submit data for children and only filed for an EUA for adolescents ages 12 to 17 in June. Novavax announced Sept. 16 that its vaccine candidate, NVX-CoV2373, will be studied in adolescents to evaluate its potential for combined regimens that mix vaccines from different manufacturers to protect against COVID-19.

PDUFA VII keeping pace with the present, prepping for the future

The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. PDUFA VII, which is to be presented to Congress by Jan. 15, is no exception. With a focus on gene and cell therapies, rare diseases, real-world evidence, and digital and cloud technologies, the proposed recommendations presented at the FDA’s Sept. 28 public meeting have evolved light years from the first agreement in 1992. In addition to efforts intended to keep pace with science and technology, the PDUFA VII commitments also reflect lessons learned from the COVID-19 pandemic and, for the first time, include allergenics in the user fee agreement.

Astellas and Seagen win Japanese approval for Padcev in advanced urothelial cancer

Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan.

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