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‘Breakthrough’ Drugs Rising

Pharmaceuticals: New FDA program could cut time for approvals in half, but details are vague

by Rick Mullin
May 10, 2013 | A version of this story appeared in Volume 91, Issue 19

An investigational hepatitis C treatment from AbbVie, the pharmaceutical spin-off of Abbott Laboratories, was granted “breakthrough therapy” status by FDA this week. AbbVie’s combination therapy joins a fast-growing list of drugs in early-stage development to be labeled as such since April 1, although FDA has yet to clarify what the status entails beyond a suggestion that the agency will collaborate with drug sponsors to expedite clinical trials and application review.

The breakthrough therapy designation is part of last year’s FDA Safety & Innovation Act. In a recent speech before the Massachusetts Biotechnology Council, FDA Commissioner Margaret A. Hamburg characterized the new program as a way to boost an existing priority review process called fast track.

The criteria for awarding breakthrough therapy designation are fluid, according to Michael Kleinrock, director of research development at IMS Institute for Healthcare Informatics, who notes that the initial awards seem to have been made on a case-by-case basis. Nevertheless, he is enthusiastic about the potential. “It’s a real change in the speed with which drugs will make it from discovery to market,” he says.

Whereas the fast-track designation might shave a year off the roughly 10-year drug development cycle, Kleinrock says, candidates awarded breakthrough status could move from the start of trials in humans to the market in as little as three to five years.


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