After 7 years, EC grants approval for Merck KGaA’s MS drug

In 2011, Merck KGaA had all but given up on its MS drug after having been knocked back by both the CHMP and the FDA.

It reacted by pulling the drug from its portfolio, as well as from markets where it had received approval, including Australia and Russia.

However, the company decided to give the drug another go after re-examining data and began gathering more data on the drug to file again for approval in European markets. The long road to recovery for the drug has finally been achieved, as it received the nod from the European Commission to treat patients with highly active relapsing multiple sclerosis (RMS).

The treatment holds a key advantage over rivals through its ease of use, it requires only 20 days of oral treatment over the course of two years. In patients with RMS, trials showed that Mavenclad reduced the annualised relapse rate by 67% and the risk of six month confirmed progression on the Expanded Disability Status Scale by 86% compared with placebo.

"Multiple Sclerosis (MS) is one of the world’s most common neurological disorders. With the approval of Mavenclad in the European Union, we are pleased to offer patients and clinicians an innovative agent with a simplified dosing schedule as a new approach to managing active relapsing MS," said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck KGaA,. "This is a pivotal change in the treatment of MS which further demonstrates our unwavering commitment to advancing patient care."

New data on the drug shows that it works by lowering levels of both immune B-cells and T-cells. This has led to speculation that the drug is able to ‘reset’ the immune system, important in the treatment of MS where the immune system begins to attack the nervous system.

"Multiple Sclerosis affects more than 700,000 people across Europe and has no cure to date," said Anne Winslow, President of the European Multiple Sclerosis Platform. "New treatment options will significantly help improve the quality of life of people living with active relapsing MS."

For Merck KGaA, it means successfully bringing another drug to market after its recent major achievement with immunotherapy treatment, Bavencio. Combined, the two drugs are expected to reach $2.2 billion in sales by 2022 for the company.

Pharmafocus recently interviewed Belén Garijo to discuss Mavenclad and her career in the pharmaceutical industry – look out for the interview in the soon-to-be-released September issue of Pharmafocus.