Regulatory

Novartis bets PRV on its next big multiple sclerosis drug — eyes US, EU approvals in ’19

One of Novartis’ top late-stage candidates for multiple sclerosis is now under review on both sides of the Atlantic.

Having stoked enthusiasm for siponimod through a solid Phase III data package, the Swiss drugmaker traded in a priority review voucher at the FDA for an expedited action date around March of next year. The EMA decision, meanwhile, will likely come in late 2019.

If Novartis appears upbeat, it’s for obvious reasons.

Paul Hudson

A new commercial drug for MS could bolster Novartis’ blockbuster plans in the field, led by a Gilenya franchise that currently brings in $3 billion in revenue. Though the pharma giant has staved off generic entry — originally expected in 2019 — to the next decade, branded drug rivals abound fighting to reach patients with relapsing-remitting multiple sclerosis.

Siponimod, though, taps into secondary progressive multiple sclerosis (SPMS), a condition that develops over time in a majority of the MS patients diagnosed with the relapsing-remitting form of the disease. The drug works by binding to the S1P1 sub-receptor on lymphocytes, which prevents them from penetrating the central nervous system.

“Siponimod is the first investigational medicine to show a significant delay in disability progression in typical SPMS patients,” said Paul Hudson, CEO of Novartis Pharmaceuticals.

As we reported earlier, the drug was shown to reduce the risk of disease progression and hit a series of secondary measurements including rate of brain volume loss, the T2 lesion volume, annual relapse rate and cognitive processing speed.

Novartis’ announcement also comes days after Celgene filed some new trials for ozanimod, triggering fresh concerns that its S1P contender might not overcome the challenges that blunted its first FDA application in time — if at all. With other big players like Roche and Biogen still in the game, though, the MS competition is still heated.


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