Novartis gets EU approval for multiple sclerosis therapy Mayzent

The European Commission has approved Novartis’ Mayzent (siponimod) for use in adults with active secondary progressive multiple sclerosis (SPMS).

In recent years, drugs such as Roche’s Ocrevus have improved the treatment options available to patients with relapsing-remitting multiple sclerosis and the primary progressive form of the disease. However, there remains an unmet medical need for oral drugs that work in SPMS.

Novartis has generated data to suggest sphingosine 1-phosphate receptor modulator Mayzent is such a drug, enabling it to win approval in the US, Australia and now the European Union.

The approvals are underpinned by data from a clinical trial that compared Mayzent to placebo. In the subgroup of patients with active SPMS, use of Mayzent was associated with statistically significant reductions in the risk of confirmed disability progression (CDP). The risk reduction at three and six months was 31% and 37%, respectively.

Mayzent also improved outcomes in the overall population, driving reductions of 21% and 26% in the three- and six-month risk of CDP. However, the EU approval only covers use of Mayzent in patients with active disease, as demonstrated by relapses or imaging features of inflammatory activity.

Novartis has predicted Mayzent will be a significant drug, with CEO Vas Narasimhan tipping it to be one of five blockbusters introduced by the company over a two-year period. However, the drug has made a slow start commercially.

In October, Novartis said Mayzent revenues in the third quarter totalled $4m (€3.6m), adding that “patient onboarding... was slower due to the special needs of this population” to explain the low sales.

“We're seeing right now about a 90-day lag between initial interest in the medicine and actually getting patients fully onboard with paid RXs. We expect to work hard to shorten that time line as well as work through the backlog of patients, drive an urgency to treat, simplify the onboarding,” Narasimhan said on a conference call with investors to discuss the third quarter results.

Novartis thinks the problem is a consequence of the novel nature of Mayzent. As Novartis sees it, the lack of effective treatments for SPMS has resulted in low rates of diagnosis. To change those dynamics, Novartis is working to educate physicians and provide genetic testing.