Regulatory Focus™ > News Articles > 2019 > 2 > EMA’s CHMP Recommends Six New Medicines, Releases Outcome of Sartan Investigation

EMA’s CHMP Recommends Six New Medicines, Releases Outcome of Sartan Investigation

Posted 01 February 2019 | By Ana Mulero 

EMA’s CHMP Recommends Six New Medicines, Releases Outcome of Sartan Investigation

The European Medicines Agency (EMA) announced Friday that its Committee for Medicinal Products for Human Use (CHMP) recommended six medicines and nine indication extensions for approval, including for the first oral add-on treatment for type 1 diabetes, and issued its opinion on the sartan safety issues.

Of the six medicines that received positive CHMP opinions at its January meeting, CHMP recommended granting marketing authorization on Teva’s Ajovy (fremanezumab) for the treatment of prophylaxis of migraine and Pfizer’s Vizimpro (dacomitinib) for the treatment of non-small cell lung cancer.

CHMP also adopted positive opinions for Krka’s Atazanavir Krka (atazanavir) for the treatment of HIV-1 infection and its Febuxostat Krka (febuxostat) for the prevention and treatment of hyperuricemia. Two biosimilar medicines for the treatment of inflammatory and autoimmune diseases received positive CHMP opinions as well: Fresenius’ Kromeya (adalimumab) and Idacio (adalimumab).

Of the nine extensions of therapeutic indication, CHMP recommended granting indication extensions for AstraZeneca’s Forxiga (dapagliflozin) as the first oral adjunct treatment to insulin for certain patients with type 1 diabetes mellitus. Forxiga had been previously authorized in the EU for the treatment of type 2 diabetes. In announcing this recommendation, EMA noted “there is a need for new therapies as an adjunct to insulin therapy, to better manage blood sugar levels and other cardiovascular factors.”

Positive opinions on an indication extension for Merck’s Keytruda, Roche’s Tecentriq and Mabthera, AstraZeneca’s Edistride, Bristol-Myers Squibb’s Orencia, Sanofi’s Praluent and Abbvie’s Mavinet were adopted by CHMP. CHMP also adopted a negative opinion to refuse an EU marketing authorization for TLC Biopharmaceuticals’ Doxolipad (doxorubicin) for the treatment of breast and ovarian cancer.

On its investigation into impurities classified as probable human carcinogens that led to a large quantity of sartan recalls worldwide in 2018 and 2019, CHMP set forth certain recommendations during its meeting last month to take legal action to mitigate the impact of the drug safety scandal and prevent future reoccurrence. “Companies that make sartan blood pressure medicines are being required to review their manufacturing processes so that they do not produce nitrosamine impurities,” EMA said.

Valsartan, candesartan, irbesartan, losartan and olmesartan manufacturers will have a two-year transition period to update manufacturing processes and establish testing regimes to detect the smallest trace amounts of N-nitrosodimethylamine and N‑nitrosodiethylamine as a result of the recommendations.

EMA also noted that “companies will have to demonstrate that their sartan products have no quantifiable levels of these impurities before they can be used in the EU” after the two-year transition period. The recommendations will be sent to the European Commission for a legally binding decision. 

The outcome of CHMP’s review follows a statement US Food and Drug Administration (FDA) officials issued last month to provide updates on how it is working to address the root causes of the issue. “Our inspections did reveal systemic problems of supervision that could have created the conditions for quality issues to arise,” said FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock. FDA and EMA have collaborated throughout the investigation.


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