European Medicines Agency Recommends Slew of Drugs for Various Indications

An array of new drugs is in line for approval from the Committee for Medicinal Products, which works under the aegis of the European Medicines Agency. The Committee has recommended for approval about 15 new products that will now have to receive the final nod from regulators shortly.

Among the drugs listed for approval are: Harvoni from Gilead, Ketoconazole HRA (ketoconazole) from Laboratoire HRA Pharma, and cancer drugs Vargatef (nintedanib) by Boehringer Ingelheim and Cyramza (ramucirumab) from Eli Lilly.

Harvoni—which belongs to a new antiviral products’ generation—has been recommended for clearance for treating hepatitis C among adults. On similar lines, Ketoconazole is being pushed as a treatment option for patients suffering Cushing’s syndrome – a rare disorder related to the hormones.

The cancer drugs that have been given the green signal – and now await a final approval – are Vargatef (nintedanib) for lung cancer (non-small cell) and cyramza for gastric cancer. These drugs have been pushed for the final round of approvals on the basis of their previous records and ability to tap into unmet needs.

Among the other drugs that have been recommended for approval are Teva’s Egranli and two drugs from Almirall (Duaklir Genuair and Brimica Genuair). A slew of drugs for other indications such as COPD and asthma, opioid-induced constipation, and erectile dysfunction from other pharma companies are also in line for being approved.

Interestingly, a number of hybrid applications have been also given the green signal, and will now have to receive final approval from regulators.


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