Novartis Awarded U.S. Approval for MS Pill Gilenya
Novartis Wins U.S. Approval for MS Pill Gilenya
Adrian Moser/Bloomberg
The Novartis AG headquarters stand in Basel, Switzerland.
The Novartis AG headquarters stand in Basel, Switzerland. Photographer: Adrian Moser/Bloomberg
Novartis AG won U.S. regulatory approval to sell Gilenya, beating Merck KGaA in a race to market the first pill to slow multiple sclerosis.
The Food and Drug Administration cleared the medicine for use against relapsing forms of the neurological disease, the Basel, Switzerland-based company said today in a statement. Novartis changed the spelling of the pill’s name to Gilenya from Gilenia during the FDA’s review.
Multiple sclerosis affects 2.5 million people worldwide, many of whom have trouble sticking with current therapies because they’re difficult to use or have side effects, according to the National Multiple Sclerosis Society, a New York-based patient group. Standard treatments are injectable drugs led by Biogen Idec Inc.’s Avonex, Merck’s Rebif and Teva Pharmaceutical Industries Ltd.’s Copaxone.
“An approval should position Gilenia for blockbuster success as the first highly effective oral treatment for MS,” Emmanuel Papadakis, an analyst at Collins Stewart, said in a note to clients on Sept. 13.
The review, initially set for six months, was delayed three months when Novartis said May 25 that the FDA requested additional analysis of current data. Cladribine, from Darmstadt, Germany-based Merck, won a priority review in July, reducing to six months from 10 the time it will take the FDA to decide on approval, after the agency rejected an earlier application in November. Merck expects a decision on cladribine in the fourth quarter.
Multiple Sclerosis
Multiple sclerosis causes the body to attack nerve cells through the immune system. Gilenya, known by the chemical name fingolimod, and cladribine blunt the attack by targeting white blood cells that harm the protective coating of nerve cells. Gilenya keeps lymphocytes, a type of white blood cell, from being released into the immune system, while cladribine works by killing lymphocytes.
Cladribine was approved more than a decade ago to fight leukemia and has been approved as an MS treatment in Russia and Australia. Gilenya won approval in Russia on Sept. 10.
Three studies released earlier this year showed both pills reduce the risk of relapses and worsening disease, with the Novartis drug also providing a greater benefit than an established interferon therapy in 12 months of treatment. Though the pills work differently, both suppress the immune system, and patients who took the drugs had higher rates of infections including herpes and shingles.
Sales for a multiple sclerosis pill could “absolutely” reach $1 billion annually, the measure of a so-called blockbuster drug, said Trevor Mundel, Novartis’s head of global drug development, in a telephone interview in January.
To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net.
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net; Reg Gale at rgale5@bloomberg.net.
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