EMA Recommended 81 Medicines for Marketing Authorization in 2013

In 2013, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for human use for marketing authorization, compared with 57 in 2012. The number of medicines containing a new active substance is quite high, the agency reports, with 38 medicines containing active substances that had never been used in medicines previously. This compares with 35 in 2012, 25 in 2011 and 15 in 2010. The number of generics is stable compared with 2012 but generally decreasing over the last few years.

Two new advanced therapy medicinal products (ATMPs) were recommended for approval in 2013, bringing to four the total number of ATMPs recommended for approval by the CHMP since the legislation on advanced therapies became operational. These innovative medicines are derived from gene therapy, cell therapy, or tissue engineering.

Also, the number of recommendations for marketing approval of medicines intended for the treatment of rare diseases increased (11 in 2013 compared with 8 in 2012 and 4 in 2011). The first two two positive opinions for marketing authorizations ofbiosimilar monoclonal antibodies were released in 2013.

In 2013, 16 new medicines for the treatment of cancer were recommended for marketing authorization, of which 12 contain a new active substance. Three medicines were recommended 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. In addition, CHMP recommended the approval of four new medicines for use in patients infected with human immunodeficiency virus (HIV), all of which contain a new active substance, and five medicines for the treatment of type 2 diabetes, four of which contain a new active substance.

Special regulatory pathways to facilitate market access
In 2013, the CHMP recommended conditional marketing authorization or approval under exceptional circumstances for nine medicines including anticancer agents (Bosulif, Erivedge and Cometriq), a smallpox vaccine (Imvanex), and medicines intended for rare conditions (Lojuxta, Defitelio, Cholic acid FGK, Deltyba and Sirturo).

Also, opinions for two compassionate use programs were given in 2013 for the treatment of hepatitis C virus (HCV) infection. These programs are intended to give patients with a life-threatening, long-lasting, or seriously disabling disease with no available treatment options access to treatments that are still under development.

Negative opinions and withdrawals
In 2013, the CHMP recommended initial negative opinions for seven medicines, two of which were transformed into positive opinions following re-examination procedures. Eight applications for initial evaluation were withdrawn by the sponsors prior to CHMP opinion.Initial evaluations started
In 2013, the Agency started the assessment of 79 applications (compared with 95 in 2012) for the initial evaluation of medicines. The decrease observed is mainly due to fewer marketing authorization applications received for generics and biosimilars.

Source: European Medicines Agency