Suspensions and safety reviews from the EMA

October 1, 2010
Stephanie Sutton
Pharmaceutical Technology Europe

It?s been a busy few weeks at the European Medicines Agency (EMA), with a number of marketing authorization suspensions and safety reviews launched, including a thorough review of all bisphosphonate-containing medicines following a possible increased risk of atypical stress fractures.

It’s been a busy few weeks at the European Medicines Agency (EMA), with a number of marketing authorization suspensions and safety reviews launched, including a thorough review of all bisphosphonate-containing medicines following a possible increased risk of atypical stress fractures. Last week’s meeting of the EMA’s Committee for Medicinal Products for Human Use (CHMP) outlined some of the key decisions made by the agency in recent weeks.

Last week, the EMA recommended suspension of GlaxoSmithKline’s rosiglitazone-containing medicines Avandia, Avaglim and Avandamet (discussed in a recent PharmTech blog) because of studies questioning their cardiovascular safety. Additionally, the EMA recommended suspension of Octapharma’s Octagam — as well as a recall of all Octagam currently on the European market — following an increase in thromboembolic reactions, including stroke, myocardial infarction and pulmonary embolism. According to a statement from the EMA, the issues are thought to be related to problems with the medicine’s manufacturing process.

A number of other medicines are also under close scrutiny from the EMA because of possible safety-related issues. Recently, Sanofi Pasteur’s oral rotavirus vaccine RotaTeq was subjected to a safety review following the detection of porcine circovirus DNA fragments; however, the CHMP concluded that the vaccine does not present a risk to public health and continues to have a positive benefit-risk balance.

There is also an ongoing safety review of GlaxoSmithKline’s Pandemrix pandemic influenza vaccine after data suggested a possible link with narcolepsy. According to the EMA, there is currently insufficient evidence to substantiate this and further studies will be required. For the moment, however, the vaccine’s benefit-risk balance continues to be positive, with no restrictions issued for use.

At its latest meeting (held 20–23 September), the CHMP also announced the initiation of a review of bisphosphonate-containing medicines looking at the possible increased risk of atypical stress fractures. The CHMP has said it will thoroughly review all available data to clarify whether atypical stress fractures are a class effect of these medicines and whether this will impact the risk-benefit balance.

Additionally, the CHMP has also announced a review of the benefits and risks of Avastin following the results of a study conducted by Roche. The study was submitted in support of an application of Avastin in the treatment of breast cancer in combination with certain forms of chemotherapy. However, according to the CHMP, in comparison to results of previous studies, “this study points to inconsistencies between different trials relevant for the currently approved breast cancer indication, particularly in terms of efficacy”. The review of Avastin will assess the new data and their impact on the benefit-risk balance of the medicine.

New approvals

As well as news regarding marketing authorization suspensions and drug safety reviews, the CHMP also announced several new product approvals at its September meeting. Novartis’s Aflunov and Prepandemic influenza vaccine (H5N1) has been approved, as well as Novartis Europharm’s orphan medicine TOBI Podhaler, which is intended to suppress chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis. AstraZeneca’s Brilique and Possia also received a positive opinion for preventing atherothrombotic events in adult patients with acute coronary syndromes.

It was also announced that Merck Serono’s Movectro, intended for the treatment of multiple sclerosis, had received a negative opinion from the CHMP even though the same treatment has been approved in Australia.

According to data released by the EMA on 20 September, the agency has so far issued 28 positive opinions this year for medicinal products and one negative opinion.