Merck KGaA to Try Again for Approval of MS Drug Four Years Later

Merck KGaA has informed the European Medicines Agency that it will apply for marketing authorization for its multiple sclerosis drug Cladribine, four years after the firm withdrew its application following a negative opinion from the Committee for Medicinal Products for Human Use.

In 2011, the German drugmaker also abandoned its approval efforts in the U.S. after a meeting with the FDA deemed that data from its trials were unlikely to address the FDA’s requirements and would not provide a basis for approval.

The regulatory agencies expressed concerns over the insufficient characterization of the drug’s benefit-risk profile, Merck KGaA said.

Despite backing off potential approvals, the firm completed several clinical trials and collected additional safety information in a long-term registry. This new data will provide the basis of its new MAA, the company said.

Belén Garijo, member of Merck KGaA’s executive board, said the company has compiled rough additional data that will allow a better characterization of the benefit-risk profile of Cladribine.

Submitting a letter of intent to the EMA for Cladribine will initiate the process to address pre-submission requirements. Merck KGaA is also developing a submission plan for other regulatory agencies.

The drug, marketed under the name Movectro, did receive approval from Russian and Australian regulators, but the company pulled it from those markets following its U.S. and EMA application failures. — Kellen Owings