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EU regulator recommended 81 medicines in 2013

Published on 21/01/14 at 02:59pm

Last year the Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing approval, compared with just 57 in 2012.

The CHMP is the safety and efficacy arm of the European Medicines Agency, and makes a final recommendation on whether a drug should gain a new licence or not.

Its conclusion is then sent on to the European Commission which almost always follows its advice, and usually rubber stamps the decision within three months.

In line with the previous years, the number of medicines containing a new active substance is quite high, with 38 medicines recommended containing active substances that had never been used in medicines before, compared with 35 in 2012; 25 in 2011 and just 15 in 2010.

The regulator said that the number of generics is ‘stable compared with 2012’, but admitted that it had generally been decreasing over the last few years.

The number of recommendations for treatments combating rare diseases also steadily increased (11 in 2013 compared with 8 in 2012 and 4 in 2011).

The EMA says this shows the success of the European orphan-medicinal-product regulation, which came into force in 2000, but may also be indicative of pharma seeing the revenue potential of low-volume but high-cost drugs for rare and ultra-rare diseases.

Last year also saw the first two positive opinions for marketing authorisations of biosimilar treatments for Janssen and Merck & Co’s blockbuster arthritis drug Remicade.

More treatment options for cancer and tuberculosis

There were 16 new medicines for the treatment of cancer recommended by the CHMP last year, of which 12 contain a new active substance.

This included Roche’s Kadcyla (trastuzumab emtansine) for certain types of breast cancer, as well as Exelixis’ Cometriq (cabozantinib) for patients with progressive metastatic medullary thyroid carcinoma.

Most of these medicines are considered to be personalised therapies that designed to block the growth and spread of cancer by interfering with specific molecules involved in tumour growth, or act on the patient’s immune system.

Particularly noteworthy for the agency in the other therapeutic areas was the recommendation of three medicines for the treatment of multidrug-resistant tuberculosis, an orphan indication associated with a very high mortality rate and whose burden has rapidly increased in recent years in the absence of new treatment options.

These were Janssen’s Sirturo and Deltyba made by Otsuka (which were both given conditional licences) and Para-aminosalicylic acid, developed by Lucane Pharma.

But it was not all good news for pharma as the CHMP recommended initial negative opinions for seven medicines last year. It points out, however, that two of these were later made into positive opinions following re-examination procedures, meaning only five were fully rejected.

On the other side of the Atlantic the FDA has also released its figures for last year, showing that only 27 new drug and biologics were approved for 2013, a fairly large decline from 2012’s figure that saw 39 approvals.

Ben Adams 

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