The European Medicines Agency (EMA) is preparing to step up its conditional approval initiative to cut the time and data needed to bring new drugs to patients. Having received applications to enter 58 drugs into the program, EMA has selected a treatment based on genes, cells or tissue engineering as the first candidate to advance to the next stage.
|CHMP Chairman Tomas Salmonson|
EMA has so far declined to name the company or drug involved in the first meeting to discuss the second stage of the initiative, which is scheduled for April 7. What we do know is that EMA will be sitting down to discuss an advanced therapy, the umbrella term the regulator uses for medicines based on genes, cells or tissue engineering. The potential for such treatments to make a major difference to health outcomes in underserved patient populations means they are ideal candidates for EMA's program, but in the long term the regulator has broader ambitions for its initiative.
"I think this is a way of working that is applicable to many drugs," Tomas Salmonson, chairman of the EMA's Committee for Medicinal Products for Human Use (CHMP), told Reuters. The first crop of 8 products selected by EMA to advance through the program also includes experimental treatments for cancer and rare diseases. Each of the 8 drugs could win approval in restricted patient populations on the basis of unprecedentedly slim data submissions, after which the label will become less and less restrictive as more safety and efficacy information accumulates.
The shifting of the burden of evidence generation from pre to post-approval is part of a Europe-wide rethink on the balance between speed and safety. EMA is leading the agenda at the continent level, but member states, notably the United Kingdom, are pushing their own initiatives. Novartis ($NVS) became the latest company to advance to the first stage of the U.K.'s fast-track scheme this week when its lung cancer drug Zykadia was named a Promising Innovative Medicine. Receipt of the status is the first of two steps in the U.K.'s Early Access to Medicines Scheme (EAMS).