Bristol-Myers Squibb has withdrawn its US application for asunaprevir and daclatasvir, eight months after the combination hepatitis C treatment was received ‘breakthrough’ status from the FDA.
The move will not stop it pursuing US approval of daclatasvir, or affect its plans for the combination in certain other markets, but it does spell the end of asunaprevir’s chances in the US.
BMS said its decision was prompted by the “rapidly evolving” hepatitis C treatment landscape in the US.
The combination of NS5A replication complex inhibitor daclatasvir and asunaprevir, a NS3/4A protease inhibitor, was originally developed to meet the need of the Japanese patient population.
It was approved by Japanese regulators in July and BMS said the dual regimen still has a key role in curing patients in that country “as well as in other markets where the HCV patient population is similar to Japan”.
BMS plan to submit additional data from daclatasvir to the FDA from an ongoing trial programme in difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant and patients co-infected with HIV.
In the EU, daclatasvir – marketed as Daklinza – was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 of HCV. The drug has a European licence for use in combination with Gilead’s Sovaldi (sofosbuvir).