Merck KGaA failed to win U.S. regulators’ backing for its multiple sclerosis pill cladribine, shutting the German drugmaker for now out of the market for new treatments for the crippling disease.
The Food and Drug Administration asked for more analysis or additional studies to get a better understanding of the medicine’s risks, Darmstadt-based Merck said in a statement today. Merck plans to seek an end-of-review meeting with the FDA to determine whether data already collected will be sufficient to address the concerns, according to the statement.
Merck had expected to compete with Switzerland’s Novartis AG, whose drug Gilenya became the first pill in the U.S. to combat multiple sclerosis when it won approval in September. Now the German drugmaker is losing its foothold in the market as setbacks accumulate for cladribine and its older injected treatment Rebif faces competition from new therapies, said Cornelia Thomas, a London-based analyst for WestLB AG.
“In the U.S., they’re likely to lose significant market share because of Gilenya,” Thomas said in a telephone interview before the decision. Thomas rates Merck’s shares “reduce.”
The shares rose 1 cent to 65.01 euros in Frankfurt trading.
Without U.S. approval for cladribine, Merck’s sales this year are likely to climb 10 percent to 15 percent, Chief Executive Officer Karl-Ludwig Kley said on Feb. 21. That compares with an estimate of 13 percent to 18 percent if the drug had won clearance.
Withdrawn in Europe
Merck withdrew its European application to sell cladribine last month after regulators in September said the drug’s benefits don’t outweigh its risks. Cladribine, originally a cancer drug, is sold in Russia and Australia under the brand name Movectro.
Multiple sclerosis causes the body to attack nerve cells through the immune system. Both Gilenya and cladribine blunt the attack by targeting white blood cells that harm the protective coating of nerve cells. Gilenya keeps a type of white blood cell called lymphocytes from being released into the immune system. Cladribine kills the cells outright and has a more lingering effect on the immune system.
MS affects about 2.5 million people. Many patients have found it’s difficult to stick with injected therapies because they’re difficult to use or have side effects, according to the National Multiple Sclerosis Society.
Merck KGaA isn’t affiliated with Merck & Co. of Whitehouse Station, New Jersey.