ZURICH — Merck KGaA failed to win US regulators’ backing for its multiple sclerosis pill cladribine, shutting the German drug maker out of the market for new treatments for the crippling disease for now.
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. 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 United States to combat multiple sclerosis when it won approval in September. Now the German drug maker 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.
Without US approval for cladribine, Merck’s sales this year are likely to climb 10 to 15 percent, chief executive Karl-Ludwig Kley said last month. That compares with an estimate of 13 to 18 percent if the drug had won clearance.
Merck withdrew its European application to sell cladribine last month after regulators said the drug’s benefits don’t outweigh its risks. Multiple sclerosis causes the body to attack nerve cells through the immune system.
Merck KGaA isn’t affiliated with Merck & Co. of New Jersey.