The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed authorisation at the European Union level for marketing of seven candidate medicines in Europe. The final decision concerning the commercialisation approval is left to the European Commission.
IHS Life Sciences perspective | |
Significance | The Committee for Medicinal Products for Human Use (CHMP) has issued seven positive opinions for treatments seeking marketing authorisation in Europe. In addition, five medicines have received recommendation for therapeutic indication extension. |
Implications | The CHMP provided positive opinions for the approval of Novo Nordisk's obesity treatment Saxenda. Furthermore, the CHMP has recommended the suspension of marketing authorisation for drugs studied in clinical trials at GVK Biosciences' site in Hyderabad, India. |
Outlook | The positive opinions will now be reviewed by the European Commission for final approval. Upon approval, applicants will be able to market their medicines in the 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 recommended seven molecules for approval. Furthermore, the committee published five recommendations for the extension of indication. The full text is available here.
Positive recommendations for new drugs | ||
Drug | Company/organisation | Indication |
Dutrebis (lamivudine + raltegravir) | Merck & Co (US) | Treatment of human immunodeficiency virus (HIV-1) |
Ikervis (ciclosporin) | Santen (Japan) | Treatment of severe keratitis |
Kengrexal (cangrelor) | The Medicines Company (US) | Reduction of thrombotic cardiovascular events |
Orbactiv (oritavancin) | The Medicines Company | Treatment of acute bacterial skin and skin structure infections |
Raplixa (human fibrinogen + human thrombin) | ProFibrix (The Netherlands) | Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis |
Saxenda (liraglutide) | Novo Nordisk (Denmark) | Treatment of obesity |
Sivextro (tedizolid phosphate) | Cubist (US) | Treatment of acute bacterial skin and skin structure infections |
Positive endorsements for new therapeutic indications | ||
Abraxane (paclitaxel) | Celgene (US) | Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small-cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. |
Aloxi (palonosetron) | Helsinn Birex (Switzerland) | Aloxi is indicated in paediatric patients one month of age and older for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. |
Eylea (aflibercept) | Bayer (Germany) | Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). |
Jakavi (ruxolitinib) | Novartis Europharm (UK) | Polycythaemia vera (PV) Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. |
Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) | Pfizer (US) | Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults =18 years of age and the elderly. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities, as well as the variability of serotype epidemiology in different geographical areas |
Source: CHMP | ||
In addition, Nordic Group (Netherlands) has withdrawn application due to unresolved issues for the extension of indication for Teysuno (tegafur + gimeracil + oteracil) to patients suffering from advanced gastric cancer for its use in combination with platinum-based cancer medicines other than cisplatin.
The CHMP also recommended the suspension of marketing authorisation for medicines approved on the basis of clinical studies conducted by the India-based contract research organisation (CRO) GVK Biosciences in Hyderabad, India. The decision follows an investigation launched by the EMA on the basis of findings by the French medicines agency, the ANSM, of non-compliance with Good Clinical Practice (GCP) at the site. The EMA investigation was launched in October 2013 and, since its start, it has reviewed more than 1,000 medicines studied at Hyderabad (see Europe - India: 3 October 2014: EMA launches investigation into GVK Biosciences). The agency has said that for more than 300 medicines available, evidence from other studies was satisfactory. Conversely, the EMA has recommended the suspension of other medicines that lacked relevant evidence from other studies. Suspension does not apply for drugs that are essential for patients due to lack of alternatives on the market. The decision on the critical relevance of single medicines is left to member state authorities. However, for critical medicines, companies have 12 months to present additional evidence. The full list of medicines that have been suspended by the CHMP is available here.
Outlook and implications
Looking at the EMA recommendations, it is interesting to note that Novo Nordisk's obesity treatment Saxenda (liraglutide) is well positioned to receive final approval in Europe in the next two months. The medicine contains the same active ingredient as Novo Nordisk's type 2 diabetes drug Victoza. Saxenda was also approved in the US in December (see United States: 24 December 2014: US FDA approves Novo Nordisk's Saxenda for marketing). Novo Nordisk plans to commercialise Saxenda in Europe in 2015. However, the CHMP gave its backing to Orexigen (US)'s Mysimba (naltrexone + bupropion) in December for the same indication, putting it ahead of the competition.
The recommendations are positive news for the applicants; the CHMP opinion will now be considered by the European Commission for the adoption of a final decision which is expected to be issued in two months. The approval issued by the European Commission enables the manufacturers to market medicines in the European Economic Area and to seek reimbursement with national payors at member-state level.
Furthermore, the EMA decision to suspend the medicines studied at the GVK Biosciences site in Hyderabad follows the precautionary measure adopted in December by a number of EU member states, including Belgium, France, Germany, and Luxembourg, which suspended marketing authorisation for 25 generic drugs over concerns related to clinical studies carried out by GVK Bioscience in India between 2008 and 2014 (see Europe - India: 8 December 2014: EU regulators suspend marketing approvals for 25 generic drugs following questions over reliability of GVK Bioscience's clinical trial data). The number of medicines involved in the EMA suspension is significantly higher compared to the drugs suspended by national authorities in Belgium, France, Germany, and Luxembourg. Therefore, the EMA decision is binding for all 28 member states and is expected to negatively affect GVK Biosciences' business as well as manufacturers that sell these products, including generic pharmaceutical firms Teva (Israel), Abbott (US), Actavis (US), Mylan (US), and Dr Reddy's Laboratories (India).