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CHMP nods several drugs through

pharmafile | November 24, 2014 | News story | Sales and Marketing Boehringer, CHMP, EMA, Esbriet, FDA, Sanofi, nintedanib, ofev 

Ten new medicines have been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), among them breakthrough IPF drug Ofev.

Boehringer Ingelheim’s Ofev (nintedanib) is one of only two drugs currently available in the world for the treatment of idiopathic pulmonary fibrosis (IPF), a fatal lung diseases characterised by scarring of the lung tissue.

“This decision is very encouraging as patients with IPF currently have very limited treatment options,” says Professor Luca Richeldi, study investigator for Ofev’s INPULSIS trials and professor of respiratory medicine at the University of Southampton.

Ofev is already available in the US, having been approved by the FDA in October. However its rival Esbriet (pirfenidone) – originally developed by InterMune, who were acquired by Roche in September – has been available in Europe since 2011 when it became the first IPF treatment available in the world.

Esbriet took longer to make it to market in the US, however, and was in fact approved by the FDA on the same day as Ofev. The nod from the CHMP means the two drugs are now likely to go head to head in both markets.

Big pharma firms see promising approvals

The other orphan drug to gain approval from the CHMP was Sanofi’s Cerdelga (eliglustat) for Gaucher disease type 1.

There was also good news for AbbVie as the CHMP recommended two of its drugs, Exviera (dasabuvir) and Viekirax (ombitasvir/paritaprevir/ritonavir) for the treatment of chronic hepatitis C.

The CHMP says: “Both products were reviewed under accelerated assessment and belong to a new generation of antiviral products for chronic hepatitis C infection that have high cure rates and have recently reshaped the treatment landscape for the disease.”

This will be a lift for AbbVie in the wake of the collapse of its Shire merger deal, and the looming spectre of its best-selling product Humira going off-patent in 2016 – as a recent IMS health survey predicted that the world would spend $100 billion on such hep c treatments over the next five years.

Meanwhile, both Celgene’s Otezla (apremilast) and Novartis’ Cosentyx (secukinumab) were recommended as new treatments for plaque psoriasis – with Otezla also getting a nod for active psoriatic arthritis.

Shionogi’s Senshio (ospemifene) received a nod for the treatment of vulvar and vaginal atrophy, and Merck Sharp & Dohme’s Zontivity (vorapaxar) saw approval for the reduction of atherothrombotic events.

The CHMP also granted positive opinions for two new informed consent applications: Genzume’s Sevelamer carbonate Zentiva (sevelamer) for the control of blood condition hyperphosphataemia, and Teva’s Rasagiline ratiopharm (rasagiline) for the treatment of Parkinson’s disease.

Informed consent applications are based on data from a previously authorised medicine, where the drug’s maker has given consent for the use of their data in the application.

Other results

During its meeting the CHMP also recommended that the morning after pill ellaOne (ulipristal acetate) from Laboratoire HRA Pharma be available without a prescription after finding that it can be used “safely and effectively without medical prescription”.

InductOs (dibotermin alfa) from Medtronic BioPharma and Travatan (travoprost) from Alcon were shown the green light for extensions of their therapeutic indications.

There were also two application withdrawals: Baxter AG’s Ceprotin (protein C concentrate), which  was expected to be used to treat protein C deficiency, and Teva’s Egranli (balugrastim), intended to combat low white blood cell levels in chemotherapy patients.

All this brings the total number of medicines the CHMP has issued a positive opinion for in 2014 up to 75. Overall this year the Committee has also given three negative opinions, seen seven applications withdrawn, and given nods for the extension of 35 therapeutic indications.

George Underwood

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