The Spanish Agency for Medicines and Health Products (AEMPS) issued positive pre-marketing assessments of five drugs during July, one fewer than in June, to be approved in the coming months for marketing in Europe and Spain.
Implications | The AEMPS has publishes its July monthly bulletin that includes positive opinions on five medicine to be approved by the European Commission, new therapeutic indications on medicines already approved in Spain, and pharmacovigilance reports. |
Outlook | Once the European Commission approves these medicines, the AEMPS will provide information on each of them, from the data sheet and the prospectus to their conditions of prescription, use, and real availability in the market in order to facilitate their marketing in the Spanish market as soon as possible. |
The Spanish Agency for Medicines and Health Products (AEMPS) has published its July monthly bulletin that includes positive opinions on medicines to be approved, new therapeutic indications on drugs already approved in Spain, and pharmacovigilance reports. The AEMPS's July bulletin can be accessed here, in Spanish.
Positive opinions
The AEMPS issued positive pre-marketing assessments of five drugs during July, one fewer than in June, to be approved in the coming months for marketing in Europe and Spain. In these assessments, the AEMPS addressed drugs highly relevant to healthcare professionals.
One of these new drugs is Cabometyx (cabozantinib; 20-/40-/60-mg film-coated tablets), produced by Ipsen (France) and Exelixis (US), for the treatment of advanced renal-cell carcinoma (RCC) in adult patients following prior vascular endothelial growth-factor (VEGF)-targeted therapy.
Kisplyx (lenvatinib; 4-mg and 10-mg hard capsules; Eisai. Japan) also received a positive opinion for the treatment of unresectable advanced or metastatic RCC in adult patients in combination with everolimus, following one prior vascular endothelial growth-factor (VEGF)-targeted therapy.
Another leading drug that also received a positive AEMPS opinion was Onivyde (Irinotecan), produced by Baxter (UK), for the treatment of metastatic adenocarcinoma of the pancreas in combination with 5-fluorouracil and leucovorin, in adult patients who have progressed following gemcitabine therapy.
The AEMPS has also given positive opinion on Sialanar (glycopyrronium bromide), produced by Proveca (UK) and indicated for symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged three years and older with chronic neurological disorders.
The AEMPS issued a positive opinion on Truberzi (eluxadoline), produced by Aptalis Pharma (subsidiary of Allergan, US), for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults.
Outlook and implications
All five medicines were granted positive EMA recommendations by the Committee for Medicinal Products for Human Use (CHMP) in July. These are likely to be approved by the European Commission within two months, which will still fall within the third quarter of 2016 (see Europe: 25 July 2016: EMA's CHMP issues positive recommendations for eight new medicines, including Lenvima).
According to the AEMPS, it reiterated the positive opinions granted to these five medicines by the CHMP because of their clinical relevance for the Spanish healthcare professionals. According to the AEMPS, once the European Commission approves these medicines, the AEMPS will provide all information of each of them, from the data sheet and the prospectus to their conditions of prescription, use, and real availability kn the market in order to facilitate their commercialisation in the Spanish market as soon as possible.