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CHMP roundup – new drug recommendations in Europe

New medicines that won positive opinions at May’s CHMP meeting included Eisai’s Fycompa, Boehringer Ingelheim’s Jentadueto and Novo Nordisk’s Novothirteen

New medicines that won positive opinions at May's CHMP meeting included Eisai's Fycompa, Boehringer Ingelheim's Jentadueto and Novo Nordisk's Novothirteen.

Recommendations, or 'positive opinions', from the EMA advisors at the CHMP (Committee for Medicines Products for Human Use) generally translate into full European Commission marketing approval within three months.

Boehringer Ingelheim's Jentadueto
Boehringer's new combination treatment for type 2 diabetes Jentadueto is a twice-daily pill that brings together Trajenta (linagliptin) with the older diabetes drug metformin.

It was backed by the CHMP for use alongside diet and exercise to improve glycaemic control in adult patients who are inadequately controlled on their maximum tolerated dose of metformin or who are already being treated with Trajenta and metformin

Boehringer is jointly developing and marketing Trajenta with Lilly and the partners won US approval for their Jentadueto combination in March.

Eisai's Fycompa
Eisai's potential first-in-class, once-daily epilepsy treatment Fycompa (perampanel) was recommended on the back of phase III data showing its ability to reduce the frequency of seizures.

Eisai is seeking a license for Fycompa as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.

The drug is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA) glutamate receptor on post-synaptic neurons (N03AX22).

The most common side effects are dizziness and somnolence and as part of its marketing authorisation a pharmacovigilance plan for Fycompa will be implemented. 

Almirall's aclidinium
The CHMP gave a positive opinion to Almirall's new chronic obstructive pulmonary disease (COPD) drug aclidinium, which was recommended as a maintenance bronchodilator treatment to relieve symptoms in adult patients.

The Spanish pharma firm, which also hopes to gain US approval for the drug this year, plans to market aclidinium under the brand names Eklira Genuair and Bretaris Genuair in Europe. 

Once the drug is approved in Europe Almirall said it would pave the way for the subsequent introduction of combination products for COPD the company has in late stage development.

Novo Nordisk's Novothirteen
EMA scientific advisors at the CHMP also gave a positive opinion to Novo Nordisk's long term prophylactic bleeding treatment for use in patients aged six and over with congenital factor XIII A-subunit deficiency.

If approved, the once-monthly replacement therapy Novothirteen (catridecacog) will be the first drug option for the rare, serious bleeding condition, which is currently treated by blood transfusions. Factor XIII deficiency is estimated to affect just 300 patients in Europe and only 900 globally.

“The development of [Novothirteen] for a very small patient community with a serious bleeding disorder demonstrates our commitment to develop a broad and innovative pipeline of molecules to fulfil unmet medical needs within haemophilia and rare bleeding disorders,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk.

• There were also CHMP decisions this month on Pradaxa's labelling and recommendations for Pfizer's Inyta and Vertex Pharma's cystic fibrosis treatment Kalydeco

28th May 2012

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