FDA amends, rather than rescinds, BMS HCV 'breakthrough'
This article was originally published in Scrip
Bristol-Myers Squibb said on 20 May it was able to provide the FDA with additional data that prevented the company from losing another one of its breakthrough therapy designations for one of its daclatasvir-based hepatitis C virus (HCV) regimens.
BMS said the breakthrough therapy designation (BTD) was for one of the company's daclatasvir-sofosbuvir regimens.
This past February, the FDA notified the company the agency planned to rescind BTDs awarded to three of its daclatasvir-based HCV regimens, although the firm only disclosed two were affected at that time, since it had not publicly acknowledged it had actually gained a third one, a spokesman told Scrip on 20 May.
Merck had received a similar notice from the FDA for that company's HCV combination product grazoprevir/elbasvir (MK-5172/MK-8742).
The FDA had cited the availability of other recently approved treatments for genotype 1 (GT-1) patients as its reasoning behind rescinding BMS' and Merck's BTDs.
Gilead Sciences and AbbVie both recently brought new HCV combination drugs to the US market, which have essentially provided a cure for the disease – Harvoni (ledipasvir-sofosbuvir) and Viekira Pak (paritaprevir/ritonavir/dasabuvir), respectively.
Merck, however, worked with regulators to find a more focused indication for the firm's combination HCV drug grazoprevir/elbasvir (MK-5172/MK-8742) and the FDA ended up replacing the BTD rather than rescinding it.
While BMS accepted the FDA's decision for the agency to take back two of the BTDs earlier awarded to the regimens related to daclatasvir, the company submitted data from its Phase III ALLY-1 trial evaluating a 12-week regimen of the drug plus Gilead's Sovaldi (sofosbuvir) and the FDA decided to amend, rather than rescind, the breakthrough status for the third regimen.
The amended BTD reflects the data on HCV GT-1 patients with advanced cirrhosis and those who develop GT-1 HCV recurrence post-liver transplant, BMS said.
BMS said the FDA first granted a BTD for the daclatasvir-sofosbuvir combination in 2013.
The company emphasized the daclatasvir-sofosbuvir regime with the amended BTD is separate from the one in which the company has a new drug application before the FDA, which the agency accepted in March.
That application is targeting HCV patients with genotype 3, which affects 54.3 million people worldwide.