Mavenclad Wins EU Approval After Reversal; FDA Application Coming Soon


Six years after it was initially rejected by regulators, a new relapsing remitting multiple sclerosis drug has been approved for sale in Europe.

Klaus Schmierer, PhD

A prominent relapsing-remitting multiple sclerosis (RRMS) drug that was rejected by regulators and shelved for several years has now been approved in Europe following the publication of new studies highlighting its efficacy and contradicting earlier concerns about side effects.

Cladribine (Mavenclad) won approval late last month from European regulators to be sold as a treatment for highly active RRMS. The drug is being marketed by Merck KGaA, the German drugmaker, known as EMD Serono in the US.

The approval breathes new life into a drug that once faced a wall of opposition from regulators. The drug was rejected by the US Food and Drug Administration (FDA) in 2011, in part due to concerns that it might be associated with cancer risk. However, in the intervening years, the cancer concern was debunked, and additional research and analysis affirmed the drug’s effectiveness.

In fact, the most recent positive research came just days before the drug was approved in Europe on August 25.

In a post-analysis published last month, a research team led by Klaus Schmierer (pictured), PhD, at Queen Mary University of London (QMUL) showed that Mavenclad significantly improved self-reported quality of life scores in patients with RRMS, at a rate much higher than placebo. The data were obtained through a Freedom of Information Act request.

The new study is based on the CLARITY Phase III trial, which was published in 2010 and involved more than 1,300 patients. The quality of life surveys covered mobility, self-care, ability to go about usual activities, pain, and anxiety.

The researchers found that patients who used Mavenclad had improved quality of life, particularly in the category of self-care, compared to those who took placebo. The findings held up for patients who took 5.25 mg doses, and for patients who took a smaller, 3.5 mg dose. In the original study, there was no difference in efficacy between the 2 dosing groups.

The other key development in Mavenclad’s turnaround story was a 2015 study that found there was no heightened cancer risk associated with taking cladribine. The study found that earlier data suggesting an increase in cancer risk was anomalous.

Now that the drug is available in Europe, EMD Serono says it will try again to gain approval in the US and other countries.

Andrew Powaleny, the director of public affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), said the Mavenclad case demonstrates the many obstacles drugs must overcome before they reach the market, noting that just 12% of drugs that enter a Phase I trial end up gaining FDA approval.

“Researching and developing innovative treatments for patients is a long and challenging process,” he told MD Magazine. “Despite these high challenges, biopharmaceutical researchers use setbacks to refine research and look for new avenues at tackling disease.”

In the case of EMD Serono, the company initially announced in 2011 that it would no longer seek to market the drug. But after the 2015 cancer study came out, the company changed its mind.

There’s no word yet on when the company will file for FDA approval, or when the drug could eventually be available in the US.

The study, “Positive impact of cladribine on quality of life in people with relapsing multiple sclerosis,” was published online in Multiple Sclerosis Journal last month.

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