Bristol-Myers Squibb withdraws potential hep C combo therapy

October 8, 2014

Bristol-Myers Squibb (BMS) will not pursue FDA approval of its hepatitis C (HCV) treatment, a dual regimen of daclatasvir and asunaprevir, and has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.

Bristol-Myers Squibb (BMS) will not pursue FDA approval of its hepatitis C (HCV) treatment, a dual regimen of daclatasvir and asunaprevir, and has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.

BMS will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

“BMS’ decision to drop pursuit of this previously-promising hep C pipeline treatment definitely comes as a surprise to most who have been closely monitoring drug development in this area,” according to FormularyWatch Clinical Editor David Calabrese, RPh, MHP, chief pharmacy officer of Catamaran.

“This discontinuation is likely to be met with great disappointment within the managed care setting, where payers have been looking forward the potential for greater competition amongst a wider array of products in this therapeutic area as a way to provide some relief to the enormous financial impact most have felt this past year within this class,” he said.

BMS cites a “rapidly evolving hepatitis C (HCV) treatment landscape in the U.S.,” as the reason for the decision. Indeed, the HCV drug pipeline is looking fairly robust. Gilead's Sovaldi reaching blockbuster status; in addition, the company is pursuing its investigational once-daily tablet combining the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg, for treating chronic HCV. AbbVie and Merck also have their own HCV drug cocktails in the works.

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