Europe's Committee for Medicinal Products for Human Use (CHMP) today released the report from its October meeting, with highlights including GlaxoSmithKline's Avandia (rosiglitazone), Atripla (efavirenz, emtricitabine, tenofovir disoproxil), clobutinol cough products and biosimilar approvals.
In-PharmaTechnologist.com brings you the highlights of the CHMP's October plenary meeting.
GSK has been having some trouble with its diabetes drug Avandia, with negative publicity already having hit the UK company's market share and revenues.
While the drug is still the subject of a US Food and Drug Administration (FDA) review regarding the potential cardiovascular risks associated with its use (along with thiazolidinediones in general), Avandia has been less hard hit in European markets.
In its October meeting, the CHMP announced the conclusion of the re-assessment of Avandia in light of the cardiovascular scares, and confirmed its opinion that the benefits of the drug still outweigh the risks.
However, the agency did recommend changing the product labelling, updating it to include a warning that patients with ischaemic heart disease should only use the drug after careful evaluation of the individual's risk, and that rosiglitazone and insulin should only be used in combination in exceptional cases and under close supervision.
The agency also recommended that further studies be carried in order to increase the level of scientific knowledge regarding rosiglitazone and another antidiabetic drug, Takeda's Actos (pioglitazone).
Atripla (efavirenz, emtricitabine, tenofovir disoproxil), the three-in-one HIV-1 treatment from Bristol-Myers Squibb, Gilead Sciences and Merck Sharp & Dohme, was one of seven positive opinions issued by the CHMP on initial marketing authorisation applications in October.
Atripla is the first fixed dose combination of HIV drugs efavirenz, emtricitabine and tenofovir disoproxil, which the regulators believe could offer a simplified treatment regimen for HIV patients through its single tablet, once-a-day dosing regime.
This month's CHMP meeting also saw the recommendation for all cough medicines containing clobutinol to lose their marketing authorisation, following an alert from the German authorities in September.
Marketing authorisations were suspended in Germany last month following preliminary study results which suggested clobutinol use was linked to a prolongation of the QT interval which can affect heartbeat and lead to irregular heart rhythm or fainting.
Boehringer Ingelheim was responsible for marketing the majority of these cough medicines under the name Silomat, and voluntarily withdrew the products from the market at the end of August.
The CHMP also recommended the revocation of marketing authorisations for a number of generic products containing cetirizine dihydrochloride, an antihistamine present in a number of hayfever treatments.
The recommendation follows on from a 2006 review which resulted in a number of national marketing authorisations being suspended due to concerns regarding good clinical and laboratory practice compliance.
With a subsequent study suggesting that these issues have yet to be resolved, and bioequivalence with the reference product unable to be established, the CHMP has proposed the full revocation of marketing authorisations for the generic medicinal products.
Two biosimilars gained positive opinions from the CHMP in October, Silapo (epoetin zeta) from Stada Arzneimittel and Retacrit (epoetin zeta) from Hospira. Both medicinal products were shown to be similar to the reference product, Janssen-Cilag's Eprex (epoetin alpha), and are intended for the treatment of anaemia associated with chronic kidney disease, and in oncology patients with anaemia.