FDA updates for week of October 11, 2021


In COVID-19 News: Advisory Board recommends both J&J and Moderna recall, Regeneron seeks full approval for its treatment, and Merck requests EUA for treatment. In cancer, the FDA approves Verzenio for early breast cancer, Keytruda for advanced cervical cancer, and Tecentriq for early non-small cell lung cancer.

Advisory committee recommends Moderna COVID-19 recall.

The FDA’s Advisory Committee on Vaccines and Related Biologics Recommended a Booster of Moderna’s COVID-19 Vaccine for High-Risk People Over 65 and 18-64 Exposed in the Workplace or high risk. All 19 committee members voted in favor of the booster dose, which will be given at least six months after the second dose in the first series. The booster will be at a dose level that is half of what the two doses are.

Separately, on August 13, the FDA approved an update to the emergency use authorization for the Moderna COVID-19 vaccine to include a third dose at the dose level of 100 µg for immunocompromised people aged 18 or over. most in the United States who have undergone solid organ transplants, or who are diagnosed with conditions that are considered to have an equivalent level of immunosuppression.

The FDA Advisory Committee recommends approval of the J&J COVID-19 recall.

The FDA’s Advisory Committee on Vaccines and Related Biologics has recommended authorizing a second dose of Johnson & Johnson vaccine as early as two months after the initial dose.

J&J had submitted data to support its emergency use authorization request in early October 2021. The submission includes recent results from the Phase 3 ENSEMBLE 2 study which found a booster of the J&J COVID- vaccine. 19 given 56 days after primary dose provided 94% protection against moderate to severe / critical COVID-19 and 100% protection against severe / critical COVID-19, at least 14 days after booster vaccination.

Regeneron is seeking full approval for COVID-19 treatment.

The FDA has accepted Regeneron’s request for full approval of REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in outpatients and as prophylaxis in certain individuals. The FDA has set a target action date of April 13, 2022. The agency plans to hold an advisory committee meeting to discuss this request before that date.

The biologics license application is supported by two positive phase 3 trials involving more than 6,000 patients in outpatients and on prophylaxis. A second BLA submission focused on treating patients hospitalized with COVID-19 is expected to be submitted later this year.

REGEN-COV is currently available under emergency use authorization to treat people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19 infection and who are either already infected (not hospitalized) or at a certain post. -exposure prophylaxis parameters

Merck seeks EUA treatment for COVID-19.

Merck has submitted an Emergency Use Clearance (EUA) application to the FDA for molnupiravir, an investigational oral antiviral drug, for the treatment of mild to moderate COVID-19 in adults at risk of progressing to COVID -19 severe and / or hospitalization.

Submission is based on positive results from a planned interim analysis of the MOVe-OUT Phase 3 clinical trial. In the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%. The incidence of drug-related adverse events was 12% in the molnupiravir group versus 11% in the placebo cohort, and fewer subjects in the molnupiravir group discontinued treatment due to an adverse event compared to the placebo group.

The FDA approves Keytruda for advanced cervical cancer.

The FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 treatment, in combination with chemotherapy, with or without Roche’s Avastin (bevacizumab), for the treatment of patients with cervical cancer. persistent, recurrent or metastatic uterus.

The approval is based on the phase 3 KEYNOTE-826 trial, which found that Keytruda plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without Avastin demonstrated overall survival and progression-free survival.

In addition, more patients responded in the Keytruda arm than to chemotherapy with or without Avastin, with an objective response rate of 68%. Among the patients who responded, the median duration of response was 18.0 months.

The FDA clears Verzenio de Lilly for early breast cancer.

The FDA has approved Eli Lilly and Company’s Verzenio (abemaciclib), the first and only CDK4 / 6 inhibitor approved for patients with specific types of breast cancer.

Verzenio, in combination with hormone therapy (tamoxifen or an aromatase inhibitor), is indicated for the adjuvant treatment of patients with positive hormone receptors (HR +), human epidermal growth factor receptors 2-negative (HER2-), lymph nodes, early breast cancer and high risk of recurrence a Ki-67 score of ≥20%, Lilly said in a press release.

In addition, the FDA has approved Agilent Technologies’ Ki-67 IHC MIB-1 pharmDx (Dako Omnis) as an aid in the identification of early breast cancer patients at high risk of disease recurrence. It is the first IHC test measuring Ki-67 expression to receive FDA approval for treatment with Verzenio and was developed in collaboration with Lilly.

The FDA approves Tecentriq for the early treatment of non-small cell lung cancer.

The FDA has approved Genentech’s Tecentriq (atezolizumab) as a post-surgery and chemotherapy treatment for adults with stage II-IIIA non-small cell lung cancer (NSCLC).

The approval is based on the results of an interim analysis from the phase 3 IMpower010 study which showed that treatment with Tecentriq after platinum-based surgery and chemotherapy reduced the risk of disease recurrence or death. 34% in people with stage II-IIIA NSCLC whose tumors express PD-L1≥1%, compared to best supportive care.

Tecentriq’s safety data was consistent with its known safety profile and no new safety signals were identified. Fatal and serious side effects occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq. The most common serious side effects were pneumonia, pneumonia and fever.

Ocular Therapeutix ophthalmic inserts are gaining in indication for itchy eyes.

Ocular Therapeutix today announced that the FDA has expanded the approval of its dexamethasone ophthalmic inserts to include an indication for the treatment of itchy eyes associated with allergic conjunctivitis.

The inserts, sold under the Dextenza brand, were initially approved in November 2018 as a treatment for eye pain after ophthalmic surgery with post-surgical eye inflammation treatment added as an indication in June 2019.

FDA approves first treatment for rare immune disorders.

The FDA has approved Enzyvant Therapeutics’ Rethymic (allogenically-agdc-treated thymus tissue), a unique therapy for immune reconstitution in pediatric patients with congenital athymia. Rethymic is human thymic tissue designed to regenerate thymic function.

Pediatric congenital athymia is ultra-rare with an estimated incidence of approximately 17 to 24 live births each year in the United States. Children who have this condition are born without a thymus. The thymus is part of the lymphatic system and plays a central role in the immune system. Children born with this disease are immunocompromised and are very susceptible to life-threatening infections.

Otsuka and Lundbeck submit sNDA for Rexulti in adolescent with schizophrenia.

The FDA has accepted an additional new drug application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti (brexpiprazole). The FDA has granted priority review to Otsuka and Lundbeck.

Up to a third of patients with schizophrenia develop the disease during adolescence. Currently, Rexulti is approved in the United States for the treatment of schizophrenia in adults and the adjunct of major depressive disorder in adults.

The submission was completed a year ahead of schedule. This was made possible by performing an extrapolation analysis using data from previous studies in adult patients, pharmacokinetic results from adult and pediatric trials, and six-month data from the long-term open-label trial. ongoing in adolescent patients with schizophrenia.

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