NEW EU DRUG APPROVALS GREW 42% IN 2013

by Shida Chayesteh

The number of new drugs approved in the EU rose by 42% in 2013 compared with the previous year, the European Medicines Agency (EMA) said on Monday.

EMA approved 81 new drugs in 2013, up from 57 in 2012. The greatest number of approvals appeared in 2009, which hit 117, according to EMA data.

Six of last year's approvals were filed by Danish companies or their partners including Novo Nordisk, Genmab , Lundbeck and Bavarian Nordic.

One in every two applicants, the regulator said, received scientific advice from the agency's Committee for Medicinal Products for Human Use (CHMP) during the development phase of their medicine.

According to EMA, following such advice significantly increases the probability of a positive outcome, with a 90% success rate for companies that request and follow scientific advice compared with 30% success for companies that do not.

Over the past five years, from 2009 to 2013, the average number of new drug approvals per year was 78.6.

"I think the increase reflects that many pharmaceutical companies are in a situation of patent gaps and would like to get some drugs on the market to compensate for the patent expirations," analyst Soren Hansen from Sydbank told Reuters.

In comparison the U.S. Food and Drug Administration (FDA) approved 27 new drugs in 2013, down from a banner year in 2012 which saw 39 drugs approved, the greatest number since 1997 according to FDA data.

But in the future there may well be fewer European approvals, while the U.S. could see higher numbers, Hansen of Sydbank said.

"The U.S. market is a more attractive market to enter because they are more willing to pay for new medicines and innovation," Hansen said.

Danske Bank said in a note to clients on Monday it expected no major launches from Denmark's Novo Nordisk in the U.S. in 2014, but added the company had the potential to launch ten new products in the U.S. from 2014-18.

Fuente: Reuters Health Information

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