In this week’s news, tainted valsartan drugs recalled in Europe, Ireland warns of post-Brexit shortages, EU close to approving first CAR-Ts, and more…
EMA orders recall of some valsartan heart drugs over concerns about API
The EMA is reviewing the safety of heart drugs containing the ingredient valsartan made by API firm Zhejiang Huahai.
The regulator announced the review last week, explaining it was prompted by the detection of an impurity called N-nitrosodimethylamine (NDMA) in valsartan supplied by the Chinese firm. NDMA is a probable carcinogen.
The EMA said it will investigate the levels of NDMA in the medicines and look for possible impact on patients who have been taking them. The agency will also consider measures to eliminate the impurity from future batches produced by the company.
Valsartan was developed by Novartis and sold as Diovan. It is used to treat high blood pressure as well as being given to patients who have had heart failure or heart attack.
National authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.
The EMA has not said how many products are involved.
Brexit will cause drug shortages in Ireland says industry group
The UK’s withdrawal from the EU next year will impact drug supplies in Ireland says Medicines for Ireland.
The generics industry group issued the warning last Tuesday, pointing out that the practice known as ‘batch sharing’ – where medicines packed in the UK are often supplied to Ireland – is unlikely to continue in its current form after Brexit.
Owen McKeon, Chair of Medicines for Ireland, said, “The risk of an end to batch sharing is a concern for the pharmacy sector.
“It has always worked in favour of Irish patients who can access medicines here marketed for the much larger UK market by availing of a smaller portion of the UK’s supply.
He warned that, “If this practice cannot continue post-Brexit continuity of supply is threatened, leaving patients’ and our health system exposed to shortages.”
EMA close to approving first CAR-T therapy
The EMA’s drug review committee has recommended that Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) are approved.
If approved, the drugs would be the first chimeric antigen receptors (CAR) T-cells medicines to be cleared for use in Europe.
Both therapies were reviewed under the EMA’s PRIME scheme, which is designed to enhance support for the development of medicines that target an unmet medical needs.
Both drugs are approved in the US. Kymriah, which is used to treat acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL), costs $475,000 for a one-time treatment for ALL and $373,000 for DLBCL.
Yescarta, which is also approved for DLBCL, costs $373,000.
Also in the news
Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS), says clarity is urgently needed around Brexit. Read more at EPM Magazine.
Polio is on the rise in the Democratic Republic of Congo despite decades of effort to eradicate the virus. This article in Science examines what impact this resurgence will have on global efforts to control the disease.
Bosch is to sell its pharmaceutical packaging business. Read more at CPhI Online.
The cost of a drug that can block HIV infection is preventing people from using it according to new research. Read more at Kaiser Health News.