FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Biogen Idec's MS Drug Plegridy

Aug. 26, 2014

The FDA has approved Biogen Idec’s new multiple sclerosis treatment Plegridy, creating another opportunity for the drugmaker in the crowded MS market.

The treatment is the only pegylated beta interferon cleared for use in relapsing MS, and is applied every two weeks through a pre-filled syringe, Biogen said.

The approval was based on a two-year Phase III trial called Advance, which involved more than 1,500 MS patients. During the first year, Plegridy (peginterferon beta-1a) reduced 12-week disease progression by 38 percent compared with placebo. After the first year, patients on placebo received Plegridy for the study’s duration, Biogen said.

The nod from the FDA comes a few weeks after the European Commission granted marketing authorization for Plegridy.

Analysts largely expected the U.S. approval, and say Plegridy could become profitable for Biogen. By 2017, the drug could generate $875 million in global sales, according to a revenue model from the investment firm Cowen and Company.

Biogen already markets three other MS treatments: Avonex (interferon beta-1a), Tecfidera (dimethyl fumarate) and Tysabri (natalizumab). Biogen warned in its latest financial statement that it faces “intense competition in the increasingly crowded MS market.”

The drugmaker faces competition from Teva’s Copaxone (glatiramer acetate injection) and Genzyme’s Aubagio (teriflunomide).

“We anticipate our sources of business will stem from patients on existing marketed interferons, including Avonex, as well as newly diagnosed patients,” said spokeswoman Nicole Pacheco. She added that there are no plans for new indications of Plegridy at this time. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.