Novartis plans to file its BAF312 multiple sclerosis drugs for US approval within weeks, the Swiss drugmaker said on Friday, as it seeks to refresh its portfolio of neurological medicines that is about to be hit by patent losses.
Its MS drug Gilenya, Novartis's top-selling medicine in 2017 with revenue of USD 3.2 billion, loses protections next year, setting the stage for cheaper copies.
Consequently, the Basel-based company is banking on BAF312, which some analysts estimate could hit USD 3 billion in peak annual sales, to help retain its presence in the space.
Novartis had previously only said it would file BAF312 for approval in the first half of 2018.
In the competitive MS space, rival Roche's new drug, Ocrevus, racked up 869 million Swiss francs (USD 916 million) during the nine months of 2017 it was on the market.
In a Lancet article published on Friday, doctors heading a study of BAF312 described it as the first large trial to show superiority over a placebo in slowing disability progression in patients with secondary progressive MS (SPMS), a hard-to-treat form of the disease that follows relapsing/remitting MS (RRMS).
Novartis has said BAF312 was shown to reduce the risk of disability progression by 21 percent in SPMS patients at three months of treatment, compared with a placebo. It has also highlighted data showing that SPMS patients getting its drug showed lower rates of brain volume losses, slower increases of lesions and reduced relapses.
Novartis said it aims for a European filing for the drug, also known as siponimod, in the third quarter.
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