FDA approves Biogen’s long-acting MS drug
pharmafile | August 18, 2014 | News story | Sales and Marketing | Avonex, Biogen, FDA, MS, Rebif, plegridy, tecfidera
Biogen Idec has racked up another approval over the weekend after its latest multiple sclerosis treatment Plegridy gained FDA backing.
The US regulator says that Plegridy (peginterferon beta-1a) can be used with relapsing forms of multiple sclerosis (RMS).
Biogen’s new treatment is faster-acting than other MS treatments for the same indication, as it designed to be injected every two weeks compared with weekly injections for its older MS drug Avonex (interferon beta-1a).
This dosing is also less frequent than rival Pfizer’s established injectable medicine Rebif, which is in fact dosed more often than Avonex, and even Teva’s $4 billion a year MS treatment Copaxone (glatiramer acetate), which was recently approved in a new less-frequent dosing regimen (three times a week).
George Scangos, chief executive of Biogen Idec, says: “Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.”
Avonex has been on the market for many years but has still brought in more than $1.5 billion in the first six months of 2014, and also enjoys US patent protection until 2026.
The drug is expected to come under more pressure from newer medicines however, and Biogen is hoping its growing MS portfolio will sustain its future as a leading firm in this disease area.
This is the US company’s second MS drug approval this year, and follows European backing for its other MS treatment Tecfidera (dimethyl fumarate), which unlike Plegridy comes in a pill form.
It was first approved in the US in March 2013 and quickly became the country’s number one prescribed oral therapy for relapsing forms of multiple sclerosis, despite being the third oral MS drug to reach the market behind Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide).
The firm says that it expects Plegridy to ‘diminish’ Avonex sales and take market share from other rivals even as overall sales from the class decline with the increasing popularity of oral treatments, such as Tecfidera.
Analysts on average forecast annual worldwide sales of Tecfidera to reach $6 billion by 2019, whilst Plegridy is expected to bring in around $2 billion in peak annual sales.
Ben Adams
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