The European Medicines Agency's Committee for Medicinal Products for Human Use has issued five positive recommendations for marketing authorisation in the European Union.
IHS Global Insight perspective | |
Significance | The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has published positive opinions for commercialisation of five new compounds in the European Union. |
Implications | The opinions provided by the CHMP include TMC Pharma Services (UK)'s medullary thyroid carcinoma treatment Cometriq (cabozantinib). Meanwhile, Janssen (US)'s pulmonary tuberculosis drug Sirturo (bedaquiline) has received conditional approval for commercialisation. In addition, the committee has recommended indication extension for Boehringer Ingelheim (Germany)'s type 2 diabetes drug Jentadueto (linagliptin + metformin). |
Outlook | The positive opinions need to receive final approval from the European Commission. Positive opinions, if ratified, enable the applicants to commercialise their medicines in all 28 EU member states, as well as Iceland, Liechtenstein, and Norway. |
The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for marketing authorisation approval in the European Union for five new drugs during its meeting on 16–19 December. The CHMP also agreed an indication extension for Boehringer Ingelheim (Germany)'s Jentadueto (linagliptin + metformin) in adult patients with type 2 diabetes mellitus. The full text is available here.
Positive recommendations for new drugs | ||
Drug | Company/organisation | Indication |
Cometriq (cabozantinib) | TMC Pharma Services (UK) | Treatment of medullary thyroid carcinoma |
Izba (travoprost) | Alcon (part of Novartis, Switzerland) | Treatment of ocular hypertension and open-angle glaucoma |
Mirvaso (brimonidine) | Galderma (Switzerland) | Treatment of facial erythema of rosacea in adult patients |
Neuraceq (florbetaben (18F)) | Piramal Imaging GmbH (Germany) | Detection of beta-amyloid in the brain |
Sirturo (bedaquiline) | Janssen-Cilag (part of Johnson & Johnson, US) | Treatment of pulmonary tuberculosis |
Positive opinions for extensions | ||
Jentadueto (linagliptin + metformin) | Boehringer Ingelheim (Germany) | New indication: Jentadueto is indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin and metformin alone do not provide adequate glycaemic control. |
Source: CHMP | ||
The CHMP also issued negative recommendations for marketing authorisation for Toray International (Japan)'s Winfuran (nalfurafine) as treatment of uraemic pruritus. According to the CHMP the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently demonstrated. Furthermore, Novartis (Switzerland) decided to withdraw its application for Exelon/Prometax (rivastigmine) on the grounds of the CHMP opinion that the data provided in support of the new indication were not sufficient to grant approval.
In addition, the CHMP has agreed the implementation of recent recommendations issued by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concerning Kogenate (octocog alpha; Bayer, Germany) and Helixate NexGen (octocog alpha; Bayer) as the benefits continue to outweigh the risks in previously untreated patients with the bleeding disorder haemophilia A. However, product information for these medicines should be amended (see Europe: 9 December: EU's PRAC issues recommendation for second-generation factor VIII products Kogenate Bayer and Helixate NexGen).
Outlook and implications
The CHMP has granted conditional approval to Janssen-Cilag (part of Johnson and Johnson, US)'s pulmonary tuberculosis drug Sirturo (bedaquiline). In particular, the committee underlined that although data provided by Janssen-Cilag show that the medicine's benefits outweigh its risks, the data were not considered comprehensive. Therefore, the CHMP has recommended additional studies of the drug. It is administered as part of a combination therapy for the orphan indication of pulmonary multidrug-resistant tuberculosis in adults. Approval of Sirturo follows the recent positive opinion granted by the CHMP on two other treatments of multidrug-resistant tuberculosis, namely Deltyba (also for a conditional approval) and Para-aminosalicylic acid Lucane, recommended in the treatment of multidrug-resistant tuberculosis (see Europe: 25 November 2013: Sovaldi and Xigduo included in five new drug recommendations by EMA's CHMP).
Cometriq (cabozantinib) recommended for the treatment of medullary thyroid carcinoma, was approved in the United States in 2012 (see United States: 3 December 2012: US FDA approves Exelixis' cabozantinib for rare thyroid cancer). In addition, US firm Exelixis, which manufactures Cometriq, announced in February 2013 the signature of a three-year agreement with SOBI (Sweden) for the launch of the drug on the European market (see United States - Sweden: 22 February 2013: SOBI to distribute and commercialise Exelixis's Cometriq in Europe).