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FDA Updates for Week of October 25, 2021


In COVID-19 news, FDA issues EUA for Pfizer vaccine for children. The FDA approved a therapy for macular edema and a novel pain treatment. And Novartis submits application for new indication for Kymriah.

FDA issues EUA for Pfizer COVID-19 vaccine for children.

On Friday afternoon, the FDA issued an emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The vaccine is two-dose primary series, three weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

Earlier in the week, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 0, with one abstention, to recommend the agency grant an emergency use authorization (EUA) for the Pfizer and BioNTech’s COVID-19 vaccine in children 5 to 11 years of age.

The committee reviewed the totality of scientific evidence shared by the companies, including results from a phase 2/3 trial that included about 4,500 children 5 to 11 years of age.

The dose used was one-third of the dose given to people 12 years and older. The study enrolled 2,268, as well as 2,379 from a supplemental safety group. Participants received a two-dose regimen of 21 days apart. Pfizer leaders indicated the dose level was selected based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study.

FDA approves targeted therapy for macular edema.

The FDA has approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. Developed by Bausch + Lomb, and Clearside Biomedical, Xipere provides a targeted delivery to the back of the eye in the space between the retina and choroid.

Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss.

FDA clears novel pain treatment.

The FDA approved a first-in-class acute pain treatment. Seglentis, developed by Esteve, is made up of a co-crystal form of the anti-inflammatory celecoxib and the analgesic tramadol.

The multimodal treatment approach targets four complementary pain relief mechanisms and “offers a new treatment option for acute pain management aligned with the multimodal analgesia now considered standard of care,” the company said in a press release.

The novel co-crystal structure produces a unique pharmacokinetic profile of its active pharmaceutical ingredients compared with their individual or combined administration, according to the pharma maker.

Seglentis will be commercialized in the United States by KOWA Pharmaceuticals America.

FDA accepts Novartis’ application for new indication for Kymriah.

The FDA has accepted Novartis’ supplemental biologics license application and for Kymriah (tisagenlecleucel) in adult patients with relapsed or refractory follicular lymphoma after two prior lines of treatment. The agency has also granted priority review for this application.

If approved, this would be the third indication for Kymriah, which is an autologous, immunocellular cancer therapy that involves reprogramming a patient's own T-cells with a chimeric antigen receptor to identify and eliminate CD19-expressing cells. It is administered as intravenous infusion.

Kymriah is currently approved by the FDA, EMA and other regulatory authorities for the treatment of relapsed or refractory pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia, and relapsed or refractory adult diffuse large B-cell lymphoma.

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