Merck KGaA drug Cladribine receives negative opinion form European Medicines Agency, Focus Reports
Release Date: 2010-09-24
September 24th – German pharmaceuticals company Merck KGaA announced that a EU regulatory panel has issued a negative opinion on its multiple sclerosis (MS) management drug Cladribine. The decision was issued by the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency. Pending appeal, such a ruling will preclude Merck from marketing and selling Cladribine in European Union member states.Cladribine is an oral medication meant to combat relapse-remitting modes of MS. A pill form provides patients with a more tolerable alternative for managing their disorder—historically, MS sufferers have been reliant on injectable medications. Another oral MS medicine, Gilenya, produced by the Swiss pharmaceutical company Novartis, was just recently approved for use in Europe and in the United States. Gilenya was approved because in clinical trials, regulators were able to examine its risks with relative clarity, and decided they were reasonably limited. Cladribine, on the other hand, was found to have a potential—albeit theoretical—risk of cancer, and the EU supervisory body decided that this and other prospective adverse effects outweighed Cladribine’s benefits.
Elmar Schnee, head of the Merck-Serono division, asserted that the risk of cancer was not “statistically reliable,” and further claimed that another potential peril found by the CHMP, the development of lymphopenia, was clinically irrelevant. Schnee said that "there is a general trend for regulators to be very risk averse,” but that such behavior sometimes denies patients “very good treatment options.” Merck is dedicated to fighting the EU decision, and Schnee maintains that the company is “fully committed to the potential of Cladribine tablets.” The company is examining its options, which include a request to re-examine the drug in further clinical trials; the appeals process, especially if it garners additional trials, could take years.
Schnee says that Cladribine has “considerable support” in the MS community, and the drug has gained approval in Australia and Russia under the name Movectro. It is pending approval in the U.S., where Merck hopes the FDA will “form its own opinion,” irrespective of the EU rejection.
The negative endorsement by the CHMP comes on the heels of a string of setbacks for Merck KGaA, which includes a similarly negative decision in the EU regarding its lung cancer drug Ertibux. Cladribine was a potential blockbuster for the company; instead, following the announcement, Merck stock dropped 8.2% in Frankfurt, completely eliminating its year-to-date gains. The stock is currently trading 1.1% lower than it was at the end of last year.
| Type: | NORMAL |
| Company: | Focus Reports |
| Country: | Switzerland |