Bisphosphonates, Approvals And Ongoing Studies At The EMA

April 22, 2011

The EMA has concluded a class review of bisphosphonates, adopted a number of positives opinions for new medicines and revealed more about the ongoing studies regarding GlaxoSmithKline's Pandemrix pandemic influenza vaccine and a possible link with narcolepsy.

The EMA has concluded a class review of bisphosphonates, adopted a number of positives opinions for new medicines and revealed more about the ongoing studies regarding GlaxoSmithKline’s Pandemrix pandemic influenza vaccine and a possible link with narcolepsy. The activities were announced in a statement issued by the EMA following a recent meeting of its Committee for Medicinal Products for Human Use (CHMP).

Bisphosphonates review

The CHMP has concluded that rare atypical fractures of the femur are a class effect of bisphosphonates. However, the committee also believes that the benefits of such medicines in the treatment and prevention of bone disorders continue to outweigh their risks. Following the results of the class review, a warning about the risk of atypical femoral fractures will be added to the prescribing information for all bisphosphonate-containing medicines in the EU. The CHMP added that such warnings had already been included in the product information for alendronate-containing medicines across Europe following a review in 2008.

New medicines

The CHMP has announced positive opinions for two medicines: Eli Lilly’s Bydureon (exenatide) for the treatment of Type II diabetes in adults and Bristol-Myers Squibb’s Nulojix (belatacept) as part of a combination treatment for prophylaxis of graft rejection in adults receiving a renal transplant.

According to statistics released by the EMA last week, the agency has issued a total of 17 positive opinions so far this year. Looking at marketing authorisation applications, the EMA has started 18 applications so far this year, and finalised a further 18.

In its meeting highlights, the CHMP also announced that it has concluded a re-examination of Roche’s Avastin, which had previously been given a negative opinion, related to the drug’s use as a first-line treatment in combination with capecitabine in metastatic breast cancer patients. The CHMP has now issued a positive opinion for the drug in such patients in whom treatment with other chemotherapy options is not considered appropriate.

Pandemrix studies

For some time, the EMA has been examining GlaxoSmithKline’s Pandemrix vaccine losely following a series of potentially related narcolepsy cases. The CHMP has now recommended that the product information be amended to advise prescribers about the preliminary results from epidemiological studies, and to perform an individual benefit–risk assessment when considering the use of the medicine in children and adolescents.

“The CHMP reviewed all available data, including new findings from Sweden and France on the suspected link between narcolepsy in children and adolescents and Pandemrix,” said a statement from the EMA. “The CHMP concluded that, following the earlier results of an epidemiological study from Finland, the new evidence strengthened the signal in children and adolescents, but that the data had methodological limitations. The relationship between Pandemrix and narcolepsy is still under investigation.”

The final review on Pandemrix and narcolepsy is expected to conclude in July 2011.

www.ema.europa.eu