FDA Updates: Alkermes Gets CRL on Manufacturing Issues; Missed Deadline on Liso-Cel; Lupin Seeks New Solosec Indication


Manufacturing issue creates setback for Alkermes on much-anticipated therapy that mitigates weight gain.

Tablet coating issue for ALKS 3831. Alkermes announced early Tuesday that FDA had issued a complete response letter (CRL) on its new drug application (NDA) for ALKS 3831, the highly anticipated olanzapine/samidorphan combination for the treatment of adults with schizophrenia and adults with bipolar I disorder. In a statement, Alkermes said that following a remote review of its manufacturing records, FDA sought to resolve certain conditions related to a tablet coating process in the company’s Wilmington, Ohio, manufacturing facility. “The CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application,” Alkermes stated. The combination therapy, which is designed to deliver therapeutic benefits while mitigating the weight gain associated with olanzapine, received support from the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in October 2020. Sunday was the target date for action under the Prescription Drug User Fee Act (PDUFA), but action was anticipated Monday.

FDA defers action on liso-cel. FDA missed the deadline Monday for completing its review of Bristol Myers Squibb’s Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel). The chimeric antigen receptor (CAR) T-cell therapy is proposed as an option for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. Bristol Myers Squibb announced that FDA informed the company that it would not complete the review of a third-party manufacturing facility in Texas by the Prescription Drug User Fee Act (PDUFA) action date of November 16, 2020, due to travel restrictions related to the COVID-19 pandemic. The application remains under review. No new action ate was given. The BLA is based on results from the TRANSCEND NHL 001 trial, which studied 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and grade 3B follicular lymphoma. According to the company, TRANSCEND NHL 001 is the largest study of CD19-directed CAR T cells to support a BLA to date.

Supplemental NDA for Solosec. Lupin Pharmaceuticals announced Monday that FDA had accepted its supplemental NDA for Solosec (secnidazole) for the treatment of trichomoniasis in adults and adolescents, with a target PDUFA date for June 30, 2021. Trichomoniasis vaginalis is a common, non-viral, curable sexually transmitted infection (STI) that affects between 3 million and 5 million women in the United States. At present, Solosec, given in 2 g oral granules, is approved to treat bacterial vaginosis in adult women. The sNDA is based on results that show a clinically and statistically significant response rate in patients treated with Solosec compared with placebo; the cure rate was 94.9% (56/59) compared with 1.7% (1/60) for placebo. The most common adverse events were vulvovaginal candidiasis (2.7%) and nausea (2.7%).


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