EMA asks sartan makers to review manufacturing process; Alembic accused of price gouging

By PharmaCompass

2019-02-07

Impressions: 153 Article

The European Medicines Agency (EMA) has asked companies that make sartan blood pressure medicines (also known as angiotensin II receptor blockers) to review their manufacturing processes so that they do not produce nitrosamine impurities.

These recommendations follow EMA’s review of N-nitrosodimethylamine (NDMA) and N‑nitrosodiethylamine (NDEA), which are classified as probable human carcinogens and have been detected in some sartan medicines.

Companies will have a transition period to make any necessary changes, during which strict temporary limits on levels of these impurities will apply. After this period, companies will have to demonstrate that their sartan products have no quantifiable levels of these impurities before they can be used in the EU.

For the vast majority of sartan medicines, impurities were either not found or were present at very low levels.

EMA has also established temporary limits which are based on the maximum daily intake for each impurity derived from animal studies: 96.0 nanograms for NDMA and 26.5 nanograms for NDEA.

The review estimated the highest possible cancer risk with these impurities. It concluded that if 100,000 patients took valsartan from Zhejiang Huahai (where the highest levels of impurities were found) every day for six years at the highest dose, there could be 22 extra cases of cancer due to NDMA over the lifetimes of those 100,000 patients. NDEA in these medicines could lead to eight extra cases in 100,000 patients taking the medicine at the highest dose every day for four years.

Meanwhile, a company in India has been accused of price gouging during the valsartan episode. Teva Pharmaceutical and Prinston Pharmaceutical recalled medications with valsartan API after testing revealed small amounts of a probable carcinogen. The same drugs produced by Alembic Pharmaceuticals did not show contamination, prompting the India-headquartered company to significantly increase prices.

In the wake of recalls by its competitors, Alembic trebled the price of 17 of its own formulations of valsartan in July last year. Those price hikes ranged from 329 percent to 469 percent, according to data from the healthcare analytics firm Elsevier. Later, the recall widened to include versions of the common blood pressure drug irbesartan. Alembic raised the price of its irbesartan too.

The strategy paid off — the valsartan price hike was among the primary reasons Alembic had “massive growth” in US sales from July through September, Pranav Amin, managing director of Alembic said, adding that it aims to “create a nimble supply chain that can react quickly to market opportunities”.

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