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FDA Updates for the Week of October 11, 2021

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In COVID-19 news: An advisory committee recommends both J&J’s and Moderna’s booster, Regeneron seeks full approved for its treatment and Merck seeks EUA for treatment. In cancer, the FDA approves Verzenio for early breast cancer, Keytruda for advanced cervical cancer, and Tecentriq in early nonsmall cell lung cancer.

Advisory committee recommends Moderna COVID-19 booster.

The FDA’s Vaccines and Related Biological Products Advisory Committee recommended a booster of Moderna’s COVID-19 vaccine for people over age of 65 who are at high risk and people 18 to 64 with workplace exposure or at high risk. All 19 members of the committee voted to support 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 100 µg dose level for immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

FDA advisory committee recommends approval of J&J COVID-19 booster.

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

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

Regeneron seeks full approval of COVID-19 treatment.

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

The biologics license application is supported by two positive phase 3 trials involving more than 6,000 patients in non-hospitalized patients and as prophylaxis. A second BLA submission focusing on the treatment of patients hospitalized due to COVID-19 is expected to be submitted later this year.

REGEN-COV is currently available under an emergency use authorization to treat people with mild-to-moderate COVID-19 who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings

Merck seeks EUA for COVID-19 treatment.

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

The submission is based on positive results from a planned interim analysis from the phase 3 MOVe-OUT clinical trial. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by about 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 therapy due to an adverse event compared with the placebo group.

FDA approves Keytruda for advanced cervical cancer.

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

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

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

FDA clears Lilly’s Verzenio 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 endocrine therapy (tamoxifen or an aromatase inhibitor), is indicated for the adjuvant treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer and at high risk of recurrence a Ki-67 score of ≥20%, Lilly said in a news release.

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

FDA approves Tecentriq for early nonsmall cell lung cancer.

The FDA has approved Genentech’s Tecentriq (atezolizumab) as treatment following surgery and chemotherapy for adults with Stage II-IIIA nonsmall cell lung cancer (NSCLC).

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

Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq. The most frequent serious adverse reactions were pneumonia, pneumonitis, and fever.

Ocular Therapeutix ophthalmic inserts gain ocular itching indication.

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

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

FDA approves first therapy for rare immune disorder.

The FDA has approved Enzyvant Therapeutics’ Rethymic (allogeneic processed thymus tissue-agdc), a one-time therapy for immune reconstitution in pediatric patients with congenital athymia. Rethymic is engineered human thymus tissue designed to regenerate the thymic function.

Pediatric congenital athymia is ultra-rare with an estimated incidence of about 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 condition are immune deficient and have high susceptibility to potentially fatal infections.

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

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

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

The submission has been completed one year earlier than planned. This was made possible by doing an extrapolation analysis using data from prior studies in adult patients, pharmacokinetic results from adult and pediatric trials, and six-month data from the ongoing open-label, long-term trial in adolescent schizophrenia patients.

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