U.K. cost watchdog gives thumbs-up to Bristol-Myers' hep C drug

Douglas Manion

Bristol-Myers Squibb ($BMY) got a go-ahead from the U.K.'s cost gatekeeper for its chronic hep C med Daklinza (daclatasvir), a win for the company as it finds its place in a fiercely contentious hep C market dominated by Gilead Sciences ($GILD) and AbbVie ($ABBV).

The U.K.'s National Institute for Health and Care Excellence (NICE) signed off on the once-daily pill in combination with other treatments for patients with genotypes 1, 3 and 4 of the disease, backpedaling on an earlier decision in July to exclude genotype 3, a difficult-to-treat form of hep C. About 214,000 people in the U.K. have chronic hep C, and almost half of those patients--or around 100,000--have genotype 3, BMS said in a statement.

Daklinza is already approved in Europe for use with Gilead's Sovaldi to treat genotype 3 of the disease, and the all-oral combo boasts cure rates of up to 100%. But until now, most hep C patients in the U.K. with genotype 3 were restricted to interferon, the company said in a statement, which often comes with painful side effects and does not hold the promise of a cure.

"The burden of genotype 3 hepatitis C in the United Kingdom is one of the highest anywhere in Europe," Douglas Manion, BMS' head of specialty development, said in a statement. "England has now joined Italy, France, The Netherlands, Sweden, Belgium, Switzerland, Denmark, Scotland and Ireland" in approving Daclatasvir for the treatment of genotype 3 HCV, he said.

The NICE green light comes as BMS angles for a spot in the hep C market. Gilead and AbbVie already hold a lead with their hep C meds, as Gilead's Harvoni and AbbVie's Viekira Pak gobble up market share.

But BMS has found success working the edges, targeting untapped niches and recently nabbing the FDA's priority review for Daklinza three new indications for hard to treat patients. Regulators will look at how well the med works with Sovaldi to treat individuals who also have HIV-1, advanced cirrhosis or who contract hep C again after a liver transplant. Daklinza is already approved in tandem with Sovaldi to treat genotype 3 patients in the U.S.

"Hepatitis C is not a one-size-fits-all, monolithic disease," Manion said earlier this month. "Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment."

At least so far, BMS' efforts seem to be paying off. Daklinza, along with BMS' other hep C drug Sunvepra (asunaprevir) raked in $743 million in sales in Japan and Europe during the second quarter, gaining ground in two of its footholds.

- here's BMS' statement
- read the PharmaTimes story

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