FDA panel endorses Gilead, Janssen hep. C drugs

Share this article:

Gilead said on Friday that an advisory committee unanimously recommended approval of an all-oral regimen containing its hepatitis C drug sofosbuvir and ribavirin in patients with genotypes 2 and 3. Those genotypes account for the minority of patients with hep. C in the US.

The FDA panel also voted 15-0 in support of approving sofosbuvir for use with pegylated interferon and ribavirin in treatment-naïve patients with the more prevalent type, genotype 1, as well as in genotype 4.

According to ISI Group analyst Mark Schoenebaum, panelists also  voiced support for use of the regimen in treatment-experienced patients with genotype 1.

Sofosbuvir, submitted to FDA April 8, was given priority review and Breakthrough Therapy designation. A final decision is expected Dec. 8. The agency doesn't have to follow the advice of its advisory panels, but often does.

Because it's likely to be the first and likely go-to therapy among a coming wave of all-oral HCV regimens, the once-daily nucleotide analogue has been forecast to achieve sales of between $4 billion and $7 billion a year.

Sofosbuvir's recommendation came a day after an advisory panel unanimously endorsed a protease inhibitor from Janssen, simeprivir, for use with pegylated interferon and ribavirin for the treatment of genotype 1 chronic HCV patients.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.