Merck KGaA announces Rebif recommendation

Merck KGaA has announced that the new formulation of its multiple sclerosis treatment Rebif (interferon beta-1a) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The recommendation will now be considered by the European Commission before a final decision is made regarding the granting of marketing authorisation for the drug.

One-year data from a 96-week phase III trial of the new formulation of the compound were presented at the meeting of the European Neurological Society in Rhodes, with the compound available in the same strengths as its previous formulation – 8.8, 22 and 44 mcg.

Merck reports that the new formulation of Rebif was developed by Merck Serono to reduce its immunogenicity and improve injection tolerability to enhance the treatment benefit for multiple sclerosis patients.

Anthony Coombs, head of the global therapeutic area neurology at Merck Serono, commented that this positive recommendation from the CHMP is encouraging for patients across the continent.

“While Rebif is well established in the treatment of multiple sclerosis, this new formulation demonstrates our commitment to the further development of products that enhance the convenience and tolerability of treatments for patients with multiple sclerosis,” he said.

In January 2007, Merck announced the initiation of a trial investigating the benefits of adding the orally-administered cladribine to Rebif to assess its efficacy as an add-on treatment for multiple sclerosis.