Novartis AG (ADR) (NYSE:NVS)’s Farydak Gets Approval From FDA
Novartis AG (ADR) (NYSE:NVS)’s multiple myeloma treatment Farydak received FDA approval, despite an advisory panel’s recommendation against approval. The panel had voted 5 to 2 against the approval, claiming the drug’s benefits did not outweigh its risks. Novartis’ drug has been granted conditional approval, therefore the company will be required to demonstrate benefits in confirmatory trials to ensure continued approval.
Farydak is approved for the treatment of multiple myeloma patients, who have relapsed after earlier therapies. The drug has been approved as combination therapy with Takeda Pharmaceutical’s Velcade plus the anti-inflammatory drug dexamethasone, only if a patient has received at least two prior treatments. Prior treatments could include combination therapy of Velcade with some immune-modulatory drug like Celgene Corporation (NASDAQ:CELG)’s Revlimid.
Novartis AG (ADR) (NYSE:NVS)’s Farydak, compared with standard treatment, almost doubled the amount of time (to 10.6 months) it requires for the disease to progress during clinical trials. However, a wide array of serious, adverse effects were observed with the therapy, including heart problems and severe diarrhea, which are listed in a boxed warning. The drug has been approved with a Risk Evaluation and Mitigation Strategy, meant to inform health service providers of possible risks associated with a drug and how to minimize the same.
Multiple myeloma is incurable and is caused by an overgrowth of plasma cells, which displace healthy cells and hinder them from functioning properly. The disease also has a high rate of relapse. According to the National Cancer Institute, nearly 22,000 Americans are diagnosed annually with multiple myeloma and about 10,700 die from it each year.
Novartis AG (ADR) (NYSE:NVS)’s Farydak is the first among HDAC inhibitors, a new class of treatments meant to help restore cell function. Inhibition of the enzyme activity slows the over-development of plasma cells or causes these dangerous cells to die.
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