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U.K. mulls a 'breakthrough' drug program of its own

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Impressed by the success of the FDA's breakthrough therapy designation, U.K. regulators are considering a similar effort to speed the path for promising drugs, according to an industry group.

The nation's government is in the midst of "active discussion across Whitehall" on a plan that would fast-track certain treatments, according to the trade group U.K. BioIndustry Association. Under the proposal, U.K. regulators would consider licensing drugs for marketing in the country and making them available to National Health Service patients before they're approved by the European Medicines Agency, association CEO Steve Bates said in a post on the group's website.

The FDA has approved 37 of the more than 140 applications received since launching the breakthrough designation program in 2012, according to EvaluatePharma, promising a prioritized review process that could shave months off a drug's path to market. But a U.K. analog, dubbed the "promising innovation medicine" designation, could prove even more valuable to the industry, according to Bates, as it could be coupled with fast-track reimbursement for new treatments.

"The combination of the 'promising innovation medicine' designation and an Early Access to Medicines scheme should enable NHS patients in the U.K. to be amongst the first in the world to benefit from new therapies and ensure the U.K. is a world leading location to start, build and develop the biotech companies that deliver such breakthroughs," Bates wrote.

At the same time, while there's been no shortage of excitement over the FDA's program, it remains to be seen just what kind of effect it'll have on drug development in the long term. Three of the FDA's breakthrough-designated therapies have since been approved--Roche's ($RHHBY) Gazyva, Johnson & Johnson ($JNJ) and Pharmacyclics' ($PCYC) Imbruvica, and Gilead's ($GILD) Sovaldi--winning nods between one and three months ahead of schedule.

- check out BIA's post

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