Novartis’s Sandoz division has won U.S. approval for a larger dosage of its Glatopa drug for multiple sclerosis (MS) patients, ending a costly delay that allowed rival generics makers to beat it to market.
The U.S. Food and Drug Administration (FDA) approved a 40 milligrams per milliliter injection of the Novartis copy of Copaxone, Teva’s blockbuster medicine, Sandoz said in a statement on Tuesday.
Sandoz began selling a 20 mg/ml Glatopa dosage to U.S. patients with relapsing MS in 2015 but missed out on millions of dollars in sales after the double-dosage version was pushed back last year after contamination problems at the Pfizer fill-and-finish plant being used by Sandoz.
The FDA approval, which Novartis had expected in the second half of this year, could help to compensate for the recent FDA delay of a Sandoz version of GlaxoSmithKline’s asthma and COPD drug Advair, analysts said. The drug’s launch is now unlikely before 2019.
“The earlier than expected authorization (of Glatopa) and commercial launch might add an estimated $200 million to Sandoz’ 2018 top line, translating in a low-single-digit divisional growth,” said Baader Helvea analyst Bruno Bulic.
“We see … Glatopa 40mg offsetting the Advair setback and reiterate our buy rating.”
Novartis developed Glatopa with Massachusetts-based Momenta Pharmaceuticals.