The European Medicines Agency has recommended 11 originator medicines for approval in the European Union, and three medicines have received backing for marketing authorisation extension.
IHS Life Sciences perspective | |
Significance | The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has published positive opinions for marketing authorisation for 11 new treatments in the European Union. The CHMP released recommendations on new generic and hybrid drugs and marketing authorization extensions for three drugs. The EMA has also started a review of Ebola treatments that are currently in early stage development. |
Implications | Looking at the recommendation granted by the committee on new originator drugs, the CHMP has recommended Eli Lilly's Cyramza and Boehringer Ingelheim's Vargatef oncology treatments. Meanwhile, Gilead Sciences' Harvoni has also been recommended for approval in Europe. |
Outlook | EMA marketing authorisation recommendation is positive news for the manufacturers that are expected to receive final approval from the European Commission two months after the CHMP decision. Approval from the European Commission allows commercialisation of the product in the EU28 member states as well as Iceland, Liechtenstein, and Norway. |
Further to its September meeting, the European Medicines Agency's Committee of Medicinal Products for Human Use (CHMP) has published positive opinions for approval of 11 originator medicines. The committee also endorsed approval of new indications for three drugs. Finally, positive recommendations were also granted to one generic drug and three hybrid medicines. The full text is available here.
Positive recommendations for new drugs | ||
Drug | Company/organisation | Indication |
Brimica Genuair (aclidinium/formoterol fumarate dihydrate) | Almirall (Spain) | Maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease |
Cyramza (ramucirumab) | Eli Lilly (US) | Treatment of gastric cancer |
Duaklir Genuair (aclidinium/formoterol fumarate dihydrate) | Almirall (Spain) | Maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease |
Egranli (balugrastim) | Teva (Israel) | Treatment of chemotherapy-induced neutropaenia |
Harvoni (sofosbuvir/ledipasvir) | Gilead Sciences (US) | Treatment of chronic hepatitis C |
Ketoconazole HRA (ketoconazole ) | Laboratoire HRA Pharma (France) | Treatment of Cushing's syndrome |
Lymphoseek (tilmanocept) | Navidea Biopharmaceuticals (Ireland) | Used in the delineation and localisation of lymph nodes |
Moventig (naloxegol) | AstraZeneca (United Kingdom) | Indicated for the treatment of adult patients 18 years and older with opioid-induced constipation including patients with inadequate response to laxatives |
Rezolsta (darunavir/cobicistat) | Janssen-Cilag (Subsidiary of Johnson & Johnson, US) | Treatment of antiretroviral therapy (ART)-naïve adults and ART-experienced adults with no darunavir (DRV) resistance associated mutations (RAMs) |
Trulicity (dulaglutide) | Eli Lilly (US) | Treatment of adults with type 2 diabetes mellitus |
Vargatef (nintedanib) | Boehringer Ingelheim (Germany) | Treatment of non-small-cell lung cancer |
Positive endorsements for new therapeutic indications | ||
Prezista (darunavir) | Janssen-Cilag | Prezista, co-administered with cobicistat, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients |
Prezista (darunavir) | Janssen-Cilag | For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight |
Signifor 20, 40, 60 mg (pasireotide ) | Novartis (Switzerland) | Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue. |
Source: CHMP | ||
The CHMP also recommended approval of Teva (Israel)'s generic of Mylan (US)'s tadalafil for the treatment of erectile dysfunction in adult males. In addition, Teva's hybrid drug Budesonide + Formoterol Teva (budesonide + formoterol) and Vylaer's Spiromax (budesonide + formoterol) were approved for the treatment of asthma and treatment of patients with severe chronic obstructive pulmonary disease.
On the negative side, the CHMP rejected the application for extension of the therapeutic indication for Pierre Fabre (France)'s Javlor (vinflunine ditartrate); the company sought approval for the treatment of breast cancer, but the CHMP said that data did not satisfactorily support effectiveness of Javlor in combination with capecitabine.
Finally, the EMA has also announced its decision to start reviewing available data concerning Ebola candidate treatments currently in early stage development. In particular, the agency has identified a number of companies for the review, namely Biocryst (US) developing BCX 4430, Fab'entech (France) developing Hyperimmune horse sera, MAPP Biologicals (US) developing ZMAPP, Sarepta (US) developing Sarepta AVI-7537, Toyama Chemicals, Fujifilm Group (Japan) and MediVector (US) developing Favipiravir and Tekmira (Canada) developing TKM-Ebola. However, the EMA encourages other manufacturers currently developing Ebola treatments to contact the agency.
Outlook and implications
The positive decision adopted by the CHMP brings the treatments concerned closer to final approval. In particular, a decision from the European Commission is expected to come two months following the CHMP recommendation. The approval for marketing authorisation enables companies to commercialise their products in the 28 EU member states as well as Iceland, Liechtenstein, and Norway.
Among the recommendations published by the EMA, the agency has endorsed Gilead Sciences' Harvoni (sofosbuvir + ledipasvir) for its approval for the treatment of chronic hepatitis C further to an accelerated review procedure. The CHMP decision is based on data from Phase III trials ION-1, ION-2, and ION-3. Harvoni is also awaiting an upcoming decision by the US FDA.
With regard to oncology products, the EMA has recommended Eli Lilly (US)'s human monoclonal antibody Cyramza for the treatment of gastric cancer further to positive Phase III data published by the manufacturer in October 2013 (see United States: 4 October 2013: Eli Lilly presents positive results from Phase III ramucirumab trial in gastric cancer). The drug was approved in the United States in April for the same indication (see United States: 22 April 2014: Lilly's ramucirumab becomes first US FDA-approved drug for advanced gastric cancer). Eli Lilly is also on the right path to seek marketing authrisation for Cyramza in colon cancer patients further to the recently published positive results from the Phase III RAISE trial (see United States: 15 September 2014: Eli Lilly's Cyramza meets primary endpoint in Phase III colorectal cancer trial).
Boehringer Ingelheim's Vargatef has also been recommended for commercialisation by the EMA (see Germany Europe: 29 September 2014: EMA's CHMP recommends Boehringer's nintedanib for second-line treatment of adenocarcinoma NSCLC), and Eli Lilly secured a positive recommendation for its candidate diabetes drug Trulicity after demonstrating non-inferiority in a head-to-head study with Novo Nordisk (Denmark)'s Novo Nordisk's Victoza (liraglutide; see United States: 26 February 2014: Eli Lilly's dulaglutide demonstrates non-inferiority to Victoza).
Finally, the EMA's decision to review experimental Ebola medicines is directed at providing an independent review concerning efficacy and safety of the candidate treatments. The European regulator's decision is likely to help shed light on the potential of the investigational treatments, providing guidance to healthcare professionals.