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AbbVie gains inside 'breakthrough' track at FDA for hot hep C combo

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While Novartis ($NVS) is beginning to test just how valuable the FDA's new "breakthrough" status is, AbbVie ($ABBV) has now joined the ranks of pharma companies that can lay claim to boasting rights for the designation. The company says that the FDA has picked its antiviral combo--with and without ribavirin--as a new breakthrough therapy worthy of a swift review and perhaps a shortened clinical trial process ahead of a regulatory decision.

AbbVie gains an inside track at the FDA for ABT-450/r + ABT-267 + ABT-333, as it follows close behind Gilead's ($GILD) closely-watched sofosbuvir, which is now under regulatory review. ABT-450 was developed in collaboration with Enanta Pharmaceuticals, a 2012 Fierce 15 company. The FDA made its decision based on some stellar results for genotype 1 patients, with 99% of treatment naïve patients seeing a sustained response after 12 weeks of therapy. Also, 93% of prior null responders hit SVR12 as well. Just how much AbbVie will benefit, though, is yet to be seen.

The combo is already in Phase III studies as rivals race to the market with interferon-free hep C therapies.

The FDA has largely stayed in its comfort zone for the first round of breakthrough announcements, sticking with giants like J&J ($JNJ) (which has two), Merck ($MRK) and Novartis. Just days ago Bristol-Myers Squibb's hep C drug daclatasvir joined the crowd. As with AbbVie, which has already won careful attention for its breakthrough drug after posting promising data, many of these drugs are also well along the trial process, limiting the advantage that a breakthrough designation can provide. ScioDerm in Durham, NC is the only little biotech to announce its inclusion in this first round of announcements, earning the designation for its experimental therapy for a rare skin disease.   

Rivals in the race for an interferon-free hep C cocktail treatment hope to snatch a big slice of a fast-growing market. Not only is Gilead advancing sofosbuvir, it's also testing a combo of the therapy with its in-house ledipasvir. Bristol-Myers Squibb and Idenix, among others, also are in the race. And AbbVie is determined to be a player.

"We feel it reflects the potential of this regimen to be important in the treatment of HCV," said John M. Leonard, M.D., senior vice president and chief scientific officer of AbbVie. "Our HCV program is one part of our advancing pipeline which is focused on delivering innovative therapies to address pressing areas of unmet clinical need."

- here's the press release

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