The European Medicines Agency says it will not be making any recommendations until July as to whether Takeda's diabetes drug Actos should be withdrawn from the market due to a potential link to bladder cancer.
Earlier this month, France and Germany suspended use of Actos (pioglitazone) and Competact (pioglitazone/metformin) following new data from a retrospective cohort study carried out in France which appears to indicate a slight increased risk of bladder cancer with pioglitazone-containing medicines. The drug has been reviewed since March by the EMA and its Committee for Medicinal Products for Human Use (CHMP) has been discussing the matter at its regular end-of-month meeting.
The latter says that the French study "strengthened the signal of a small increased risk of bladder cancer". However, the committee found that the study had "several methodological limitations, which limit the strength of evidence provided by these epidemiological data".
These will have to be evaluated "in the context of the overall available data", noted the CHMP, adding that "at this stage there were still numerous issues that needed to be resolved before it could make recommendations on the future use of these medicines".
The CHMP has also asked its Scientific Advisory Group on Diabetes/Endocrinology (SAG-D/E) to discuss in early July the clinical relevance of the available data on the bladder cancer risk, "and to identify risk-minimisation measures for patients in clinical practice". The committee will discuss the recommendations of the SAG-D/E at its next meeting and give its final opinion.
Last week, the US Food and Drug Administration said it is adding information to label on Actos about the potential risk of bladder cancer in long-term use, while keeping the product on the market for the timebeing.
Takeda says it is "confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes". The Japanese drugmaker added that "we continuously monitor the safety and tolerability of all of our products and will continue to work with the EMA and other individual regulatory bodies to share and review all available data, and to determine appropriate next steps".
EMA and FDA set up biosimilar 'cluster'
Meantime, the EMA and the FDA say they have established a new 'cluster', this time on biosimilar drugs.
These clusters are "topic areas of mutual interest for the two agencies", they note. which they have identified as benefiting from "the regular exchange of information and collaborative meetings." Biosimilars are the latest addition to the existing list which already includes medicines to treat cancer, orphan drugs, medicines for children and blood-based products.
The new cluster will begin with a 'kick-off' meeting to discuss the group's activities and will be followed by teleconferences around three times a year. The agencies say that it is the latest step in their ongoing collaboration on regulatory issues under confidentiality arrangements which werefirst signed in 2003.
The degree of interaction between the EMA and the FDA "has increased significantly since then", they say, "to the current stable level of around 55 interactions per month".