EU Panel Backs Closer Sartan Monitoring, Generic PAH Drug

Patrice Wendling

April 26, 2019

The European Medicines Agency (EMA) is taking additional steps to avoid or keep nitrosamine impurities below acceptable levels in blood pressure and diabetes medicines.

Earlier this year, the agency set strict legally binding limits for nitrosamines in angiotensin II receptor blockers following an European Union (EU) safety review of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), two potential carcinogens that have been found in sartans sold in the Europe as well as in the United States. Companies were also required to review their manufacturing processes so they do not produce nitrosamine impurities, with a transition period allowed to make any necessary changes.

Based on these experiences, the EMA announced at its April meeting of the Committee for Medicinal Products for Human Use (CHMP) that it is launching an exercise with experts from across the EU regulatory network to consider how to prevent such incidents in the future and how their management can be improved if they occur.

In addition, the EMA and national authorities are requesting, as a precaution, that companies using certain reagents to manufacture the diabetes drug pioglitazone test their products and monitor their processes to rule out the presence of nitrosamines. The move follows the detection of low levels of NDMA in a few batches of pioglitazone manufactured by Hetero Labs in India.

Finally, CHMP gave a positive opinion for a generic version of the endothelin receptor antagonist Ambrisentan Mylan (ambrisentan) to treat pulmonary arterial hypertension (PAH) in adults, World Health Organization class II to III, including use in combination treatment.

The new generic will available as 5 mg and 10 mg tablets, the agency reported in a release. Ambrisentan Mylan is a generic of Volibris, which has been available in the EU since 2008.

Earlier this month, the US Food and Drug Administration approved four generic versions of Letairis (ambrisentan), which it approved for the treatment of PAH in 2007.

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