BMS resubmits hepatitis C drug
pharmafile | March 13, 2015 | News story | Sales and Marketing | BMS, NDA, daclatasvir gilead, hepatitis C, sovaldi
Bristol-Myers Squibb has resubmitted its hepatitis C (HCV) treatment for FDA approval despite previously backing out, as it spots a new niche to fill in an expanding market.
The application is for its investigational compound daclatasvir in combination with Gilead’s Sovaldi (sofosbuvir) for HCV genotype 3.
Currently the recommended treatment for genotype 3 is Solvadi with ribavirin for 24 weeks, but BMS says that this new combination can bring that duration down to 12 weeks, which has become the standard for other genotypes.
“The daclatasvir-based NDA seeks to address a high-unmet patient need that still exists despite recent hepatitis C treatment advances,” says Douglas Manion, head of speciality development at BMS. “Approximately 9-12% of HCV patients in the US have genotype 3. That’s thousands of individuals in the US who historically have had limited treatment options requiring at least 24 weeks of treatment.
“We also are continuing clinical trials to determine the potential of daclatasvir-based regimens in treating a range of other high unmet-need patients, including those co-infected with HIV, HCV patients with decompensated cirrhosis, and HCV recurrence in post-transplant patients.”
BMS originally submitted daclatasvir to the FDA last year in combination with its own asunaprevir, but later withdrew it due to the amount of competition it would face in the rapidly-expanding HCV market – chiefly driven by Sovaldi.
The new application follows results from the Phase III ALLY-3 trial, which found that the daclatasvir/Sovladi combination could effectively cure HCV genotype 3 in 90% of patients over 12 weeks.
Genotype 3 is the second most common HCV genotype after genotype 1 and is estimated to affect 54.3 million people worldwide. It is more aggressive than other genotypes as it is associated with progressive disease.
The combination treatment may get caught up in the huge controversy currently surrounding Solvadi, however, which has attracted ire from around the world due to its high price.
BMS says that the FDA will complete its review of the submission within six-months.
George Underwood
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