FDA Revises Bristol-Myers Squibb’s Daklinza Breakthrough Therapy

The FDA has revised Bristol-Myers Squibb’s breakthrough therapy designation for its daclatasvir/sofosbuvir combination hepatitis C therapy to cover patients with advanced cirrhosis or whose infection recurs after a liver transplant.

In February, the company announced that three combinations of Daklinza (daclatasvir) with either one or two other drugs were in danger of losing that designation in a broad population of genotype 1 patients, due to recent approvals of Gilead Sciences’ Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) and AbbVie’s Veikira Pak (ombitasvir, paritaprevir and ritonavir tablets copackaged with dasabuvir tablets).

While BMS decided not to appeal the FDA’s decision on the other combinations, it did submit results of a Phase III trial evaluating 12 weeks of Daklinza alongside Gilead Sciences’ Sovaldi and ribavirin in this narrower population, company spokesman Robert Perry said.

The trial showed that 95 percent of transplant patients and 82 percent of patients with advanced cirrhosis reached a functional cure in 12 weeks.

The drugmaker plans to file an sNDA for this indication soon. A previous application was accepted in March for the combination in genotype 3 patients. The FDA should make a decision on that by September, Perry says. — Lena Freund