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FDA Updates for the Week of Aug. 7, 2023


The FDA has approved Talvey, a new therapy for treating multiple myeloma patients. The agency has also issued a complete response letter for avasopasem for severe oral mucositis and set a PDUFA date for a monthly MS drug.

FDA Approves Talvey to Treat Multiple Myeloma

The FDA has granted accelerated approval to Talvey (talquetamab-tgvs), a first-in-class bispecific antibody to treat adult patients with relapsed or refractory multiple myeloma. It is indicated for patients who have received at least four prior lines of therapy. Developed by Janssen Pharmaceutical Company, Talvey is a weekly or biweekly subcutaneous (SC) injection after an initial step-up phase.

Multiple myeloma is an incurable blood cancer that affects plasma cells, which are found in the bone marrow. In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the United States. People with multiple myeloma have a five-year relative survival rate of 59.8%.

Talvey is a bispecific antibody that targets both CD3 receptor on T cells and GPRC5D. CD3 is involved in activating T cells, and GPRC5D is overexpressed on multiple myeloma cells. It will be available in the next few weeks and will have a price of $45,000 per month, for a range of $270,000 to $360,000, based on the typical average treatment duration of six to eight months in the clinical trial, according to a Janssen spokesperson. The company expects that Talvey will be covered by Medicare and most commercial insurance plans.

FDA Issues Complete Response for Avasopasem for Severe Oral Mucositis

FDA has issued a complete response letter for Galera Therapeutics’ avasopasem manganese. The new drug application was seeking approval to treat radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer. The agency indicated that clinical trial and supporting data did not provide evidence of avasopasem’s effectiveness and safety and requested an additional trial for resubmission.

Oral mucositis results in tissue swelling and irritation in the mouth and can be a result of chemotherapy and radiotherapy. About 42,000 patients with head and neck cancer undergo radiotherapy every year in the United States and about 70% of patients will develop severe oral mucositis during treatment. This often results in patients being hospitalization and needing feeding tubes.

In an investor call, Sorensen said Galera had conducted trials with 700 patients, including two randomized trials. Both of these met primary endpoints. He said the company plans to meet with the FDA to discuss next steps. He said the timing, size and details of a new trial would need to be discussed with the regulatory agency.

FDA Sets PDUFA Date for Monthly MS Drug

The FDA has accepted the new drug application for GA Depot (glatiramer acetate) to treat patients with relapsing forms multiple sclerosis, and assigned a PDUFA action date of March 8, 2024.

Multiple sclerosis impacts the brain and spinal cord. In MS, the immune system attacks myelin, the protective layer of nerve fibers. It causes problems with vision, arm and leg movement and balance. According to the National Multiple Sclerosis Society, nearly 1 million people are living with MS in the United States, and about 85% are initially diagnosed with the relapsing-remitting form of the disease.

Developed by Viatris and Mapi Pharma, GA Depot is a long-acting version of glatiramer acetate, which is available as generics and as the branded therapy Copaxone. Glatiramer acetate stops the immune system from attacking myelin. Available glatiramer acetate therapies involve injections three times a week, whereas GA Depot would be administered once every four weeks.

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