The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Novartis’ new drug application (NDA) and marketing authorization application (MAA) for multiple sclerosis drug siponimod (BAF312).
The regulators have accepted the firm’s filings for investigational oral and once-daily siponimod to treat secondary progressive multiple sclerosis (SPMS) in adults.
Siponimod is an investigational and selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor.
It combines to the S1P1 sub-receptor on lymphocytes, which restricts them from entering the central nervous system (CNS) of patients with multiple sclerosis.
Novartis has used a review voucher to advance the drug’s review in the US, while the regulatory action for siponimod is expected in the US in March 2019 and Europe in late 2019.
Novartis submitted application based on data from the Expand phase III study, which is a randomized, double-blind and placebo-controlled trial designed to compare the efficacy and safety of siponimod against placebo in people living with typical SPMS.
The company also carried out the Bold phase III study, which a randomized, double-blind, placebo-controlled and adaptive dose-ranging trial in patients with RRMS.
According to the company, the trial demonstrated that siponimod significantly reduced the annualized rate of relapses (ARR) over six months compared to placebo.
Swissmedic secured fast track authorization procedure for siponimod in SPMS in Switzerland.
Novartis multiple sclerosis portfolio is comprised of Extavia (interferon beta-1b for subcutaneous injection), which secured approval in the US to treat relapsing forms of MS.
Extavia was approved in Europe to treat people with relapsing-remitting MS, SPMS with active disease and people who have had a single clinical event suggestive of MS.
Ofatumumab (OMB157) is the firm’s investigational fully human monoclonal antibody for relapsing MS. It is currently being studied in two phase III pivotal studies.
Novartis Pharmaceuticals CEO Paul Hudson said: “With siponimod, we underpin our strong commitment to the MS community by reimagining care for people whose lives have been considerably disrupted by this devastating illness.
“We are closely working with the FDA and EMA to ensure siponimod is available for patients as soon as possible.”