The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted four positive recommendations for marketing authorisation for originator drugs.
IHS Global Insight perspective | |
Significance | During its January meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued four positive opinions for commercialisation of originator drugs in the European Union. |
Implications | The recommendations adopted by the committee include CTEPH treatment Adempas (riociguat; Bayer, Germany), the GLP-1 receptor agonist Eperzan (albiglutide; GlaxoSmithKline, UK), Takeda (Japan)'s schizophrenia drug Latuda (lurasidone). Post-partum haemorrhage treatment Hemoprostol (misoprostol; Linepharma, France) also received a positive opinion, exclusively intended for markets outside the EU. |
Outlook | The positive opinions will now be sent to the European Commission for final approval. If the European Commission grants its own positive opinion, the drugs will receive marketing authorisation throughout the 28 EU member states, as well as Iceland, Liechtenstein, and Norway. |
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted four positive opinions for marketing authorisation approval during its meeting held on 20–23 January. In addition, the CHMP also issued three positive opinions for indication extension for NovoThirteen (catridecacog; Novo Nordisk, Denmark), Stelara (ustekinumab; Johnson & Johnson subsidiary Janssen-Cilag, US), and Xolair (omalizumab; Novartis, Switzerland). The full text is available here.
Positive recommendations for new drugs | ||
Drug | Company/organisation | Indication |
Adempas (riociguat) | Bayer (Germany) | Treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension |
Eperzan (albiglutide) | GlaxoSmithKline (UK) | Treatment of type 2 diabetes mellitus |
Hemoprostol (misoprostol) | Linepharma (France) | Indicated in women of childbearing age for treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available |
Latuda (lurasidone) | Takeda (Japan) | Treatment of schizophrenia |
Positive opinions for extensions | ||
NovoThirteen (catridecacog) | Novo Nordisk (Denmark) | Long-term prophylactic treatment of bleeding in adult and paediatric patients with congenital factor XIII A-subunit deficiency. |
Stelara (ustekinumab) | Janssen-Cilag (Johnson & Johnson, US) | Stelara is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX), or PUVA (psoralen and ultraviolet A). |
Xolair (omalizumab) | Novartis (Switzerland) | Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adults and adolescents (12 years and above) with inadequate response to H1 antihistamine treatment |
Source: CHMP | ||
The CHMP has also given its backing to a new biosimilar medicine for commercialisation in Europe, the infertility drug Bemfola (follitropin alpha; Finox Biotech, Switzerland).
The committee expressed negative opinions on the approval of four drugs. In particular, the CHMP has rejected applications for approval from Novartis (Switzerland) for its acute heart failure treatment Reasanz (serelaxin). However, the company has already announced its decision to file for re-examination before the CHMP, with additional data to be assessed by the committee (see Switzerland: 24 November 2014: Novartis to submit package for re-examination of RLX030 for conditional approval in the EU). Similarly, Teva (Israel) and Active Biotech (Sweden) intend to apply for a re-examination of their multiple sclerosis (MS) drug Nerventra (laquinimod) after the CHMP turned down their marketing authorisation application further to the assessment of the risk-benefit profile of the drug. The CHMP has also issued negative recommendations for marketing authorisation for AB Science (France)'s Masiviera (masitinib) and PTC Therapeutics (US)'s Translarna (ataluren).
Furthermore, Toray International (Japan) decided to withdraw its application for Winfuran (nalfurafine) on the grounds of the CHMP opinion that the data provided in support of the new application do not enable the committee to adopt positive recommendations for the treatment. The CHMP has also started a review of emergency contraceptives to assess whether increased bodyweight and body mass index (BMI) have negative effects on the efficacy of these medicines.
Outlook and implications
The CHMP decision will now be sent to the European Commission for final approval which typically comes after a couple of months. Takeda's Latuda, licensed from Dainippon Sumitomo Pharma (Japan), is on good track to receiving final approval in Europe. The drug has already been approved in a number of countries worldwide such as Australia and Switzerland, and has recently been recommended by Canada's CDEC (see Canada: 7 January 2014: Canada's CDEC issues positive recommendation for Sunovion's Latuda; Switzerland: 15 August 2013: Swissmedic approves Takeda's schizophrenia drug lurasidone and Australia: 22 April 2013: Dainippon Sumitomo files Latuda for approval in Australia).
Furthermore, the recommendation granted to GSK's Eperzan (albiglutide), a once-weekly treatment for type 2 diabetes, is good news for the company which may soon be able to compete with other glucagon-like peptide (GLP-1) receptor agonists such as Novo Nordisk (Denmark)'s Victoza (liraglutide) as well as Bristol-Myers Squibb and AstraZeneca (UK)'s Byetta/Bydureon (exenatide). GLP-1 receptor agonists are major revenues generators and represent an appealing segment of the market for pharma companies interested in the diabetes franchise (see United Kingdom: 31 October 2013: AstraZeneca reports 9% fall in revenues in Q3, appoints new CFO; United States: 25 October 2013: BMS reports 9% y/y top-line growth led by 18% boost in international sales and Denmark: 31 October 2013: Novo Nordisk's year-to-date sales grow 8% y/y boosted by modern insulin division and Victoza). Sanofi (France) is also set to apply for marketing authorisation for its prandial GLP-1 receptor agonist Lyxumia (lixisenatide) which recently demonstrated good results in a Phase III trial (see France: 5 December 2013: Sanofi's type 2 diabetes drug Lyxumia meets primary endpoint in Phase IIIb study)
Meanwhile, the CHMP recommendation is also encouraging news for Bayer in regards to its CTEPH treatment following approvals in Japan and United States (see Japan: 17 January 2014: Bayer's riociguat approved for CTEPH in Japan and United States: 10 October 2013: US FDA approves Bayer's Adempas for treatment of two types of pulmonary hypertension). The drug is expected to compete with Tracleer (bosentan) commercialised by Actelion (Switzerland) as well as Gilead Sciences' Letairis (ambrisentan).
If the European Commission gives its authorisation, new biosimilar drug Bemfola may also be launched in the EU markets in the second quarter of 2014. The approval is based on Phase III data that shows biosimilarity between Bemfola and the currently available treatment.