Merck KgaA's (MKGAF) MS Drug Mavenclad Gets FDA Approval

Merck KgaA MKGAF announced that the FDA has granted approval to its oral multiple sclerosis (“MS”) drug, Mavenclad. The drug is indicated for treating adult patients with relapsing-remitting MS (“RRMS”) and active secondary progressive MS (“SPMS”).

The drug has achieved a proven efficacy of two years with oral treatment for a maximum of 20 days in clinical studies. Moreover, the drug is already approved in other geographies including Europe.

However, we note that the Mavenclad’s label contains a boxed warning for potential risk of malignancy and the risk of teratogenicity. Due to its risky safety profile, the drug is recommended for patients who are having inadequate response or are intolerable to alternative treatments. The drug is contra-indicated for clinically isolated syndrome ("CIS").

Merck’s shares have increased 11.5% so far this year compared with the industry’s rise of 17.5%.

 

In clinical studies, including follow-up studies, patients were treated with Mavenclad for a median of 4.8 years. Data from the study showed that treatment with the drug achieved 58% reduction in the annualized relapse rate compared to a placebo. Moreover, 81% of patients did not have relapses after having the short-course treatment over a period of two years versus 63% for placebo. Treatment with Mavenclad also reduced the risk of 3-month confirmed disability progression and lowered the number of injury/damage to brain (lesions).

Multiple sclerosis is a major factor leading to disability in young as well as adult patients. Per the press release, there are nearly a million people who are affected by MS in the United States. The majority (85%) is initially diagnosed with RRMS and in most cases they progress to SPMS. An oral treatment with a short course can help several of these patients, thereby creating a significant opportunity for Mavenclad. However, malignancy risk may hamper its uptake.

In 2018, Mavenclad generated sales of almost $106 million for the company. With the U.S. approval, sales are expected to get a boost.

Please note that Biogen BIIB holds a strong position in the United States with multiple drugs in its MS portfolio. Its MS drugs generated sales of almost $8.6 billion in 2018. Apart from Biogen, several pharma companies have approved treatments for MS including Roche’s RHHBY Ocrevus and Sanofi’s SNY Aubagio. Last month, Novartis’ MS drug, Mayzent (siponimod), received approval from the FDA for treating relapsing forms of multiple sclerosis, including RRMS, SPMS as well as CIS.

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