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New intramuscular administration for Biogen’s MS therapy Plegridy approved in the EU

New administration offers same efficacy as subcutaneous injection

The European Commission (EC) has approved a new intramuscular (IM) injection route of administration for Biogen’s Plegridy for the treatment of relapsing-remitting multiple sclerosis (RRMS).

Plegridy (peginterferon beta-1a) is a long-acting treatment for RRMS in which interferon beta-1a – the active ingredient in Biogen's Avonex (interferon beta-1a) – is pegylated to make the drug last longer in the body than other beta interferons.

In 2014, Plegridy was initially approved in the US for relapsing forms of MS, to be administered via subcutaneous (SC) injection every 14 days.

The new IM route of administration, while still providing patients with the same efficacy and safety of Plegridy, has the potential for reduction in injection site reactions compared to SC administration, Biogen said in a statement.

The EC approval of the new administration route is based on data which demonstrated that IM administration had an equal bioequivalence to SC administration in healthy volunteers.

In addition, the results showed that participants receiving Plegridy through IM administration experienced fewer injection site reactions compared to participants receiving SC administration – 14.4% versus 32.1%.

Biogen’s MS franchise also includes its oral therapy Tecfidera (dimethyl fumarate), although the cmpany has been facing patent challenges to the drug recently.

However, in February 2020, Biogen won a patent challenge to Tecfidera from Mylan, which focused on the ‘514 patent on the drug which is due to expire in 2028.

The Patent Trial and Appeal Board – run by the US Patent and Trademark Office – determined that Mylan did not sufficiently demonstrate its claim and dismissed the challenge.

“Mylan continues to believe, based on the law and the facts, that Biogen’s ‘514 patent is invalid and will continue its challenges in both the district court and the Federal Circuit to remove this patent from blocking generic competition to Tecfidera," Mylan said in response to the ruling.

Aside from MS, Biogen has high hopes for its potential Alzheimer’s disease therapy aducanumab, which is currently under review with the US Food and Drug Administration.

In November 2020, a panel of outside experts – the Peripheral and Central Nervous System Drugs Advisory Committee – overwhelmingly voted no on a number of counts regarding the efficacy and evidence supporting the use of aducanumab in Alzheimer’s disease (AD).

In response to the question of whether two studies – EMERGE and ENGAGE – provide ‘strong evidence’ that aducanumab is effective in treating AD, eight experts voted no, with one voting yes and two ‘uncertain’.

Although the FDA is not required to follow guidance from expert panel decisions, it usually does so. However, as no new Alzheimer’s disease therapies have been approved in over a decade, there is still hope that Biogen could score FDA approval for aducanumab.

Article by
Lucy Parsons

6th January 2021

From: Regulatory



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