AbbVie nabs quick FDA review for Viekira Pak in genotype 1b patients

Viekira Pak--Courtesy of AbbVie

AbbVie ($ABBV) knows that expanding to untapped niches is key to its hep C success, targeting small populations of patients to increase market share for its blockbuster-in-the-making, Viekira Pak. Now, with the help of a quick FDA review, the med is set to gain more ground this year.

The agency gave its priority review designation to Viekira Pak without ribavirin to treat individuals with chronic genotype 1b hep C and cirrhosis. The move comes months after AbbVie revealed some promising data for the drug from a trial with genotype 1b patients, showing that its combo med boasted a 100% cure rate.

That trial, dubbed TURQUOISE-III, is just one part of AbbVie's plan to demonstrate Viekira Pak's promise in treating different subtypes of hep C. About 2.7 million people in the U.S. have chronic hep C, and genotype 1 is the most common type. Of those patients, about 77% are genotype 1a and 23% have genotype 1b, the company said in a statement, presenting an opportunity for drugmakers like AbbVie that are trying to carve out a niche in a competitive market.

"We are pleased that the FDA has granted priority review for Viekira Pak without ribavirin as a therapy for treating GT1b chronic hepatitis C patients who have compensated cirrhosis," AbbVie CSO Dr. Michael Severino said in a statement. "The filing of this sNDA further underscores AbbVie's commitment to patients living with chronic HCV infection."

But AbbVie is far from alone in its quest for hep C dominance. The company competes head-to-head in genotype 1 with Gilead Sciences ($GILD), whose Sovaldi and Harvoni continue to gobble up market share. AbbVie gave Gilead a run for its money last year by striking an exclusive deal with Express Scripts ($ESRX) for Viekira Pak, but Gilead bounced back with a few deals of its own to hold on to its top-dog status in the market.

And Gilead is already charging ahead this year, planning to roll out a new hep C combo pill that treats genotypes 1-6 of the virus. The company got a boost earlier this week when the FDA granted the med a speedy review. Regulators are expected to hand down a final decision on the drug by the end of June.

Meanwhile, Bristol-Myers Squibb ($BMY) and Merck ($MRK) are developing their own hep C combo treatments. Merck, for one, seems confident about its prospects. The company knows "the players, and we know the managed care organizations very, very well," Adam Schechter, Merck's president of global human health, said last year. That attitude, combined with Merck's plan for tapping smaller patient pools, could mean competition for AbbVie in the year ahead.

- read AbbVie's statement

Special Reports: The new drug approvals of 2014 - Harvoni - Viekira Pak | The new drug approvals of 2013 - Sovaldi - Gilead

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