The European Medicines Agency's Committee for Medicinal Products for Human Use has issued six positive recommendations for the marketing authorisation of new drugs and one biosimilar in the European Union.
IHS Life Sciences perspective | |
Significance | The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has published positive recommendations for the marketing authorisation of six medicines in the European Union. Furthermore, the CHMP has endorsed indication extensions for seven drugs. |
Implications | Among the positive decisions issued by the CHMP, Bristol-Myers Squibb's HCV treatment Daklinza has been recommended for approval. In addition, Eli Lilly and Boehringer Ingelheim's biosimilar drug Abasria has received a recommendation from the CHMP. |
Outlook | The positive recommendations issued by the CHMP will now be reviewed by the European Commission for a final decision. This decision is usually adopted approximately two months after the CHMP's endorsements. If the commission upholds the CHMP's recommendations, the drugs will secure marketing authorisation throughout the 28 EU member states as well as Iceland, Liechtenstein, and Norway. |
The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) published on 27 June recommendations for the marketing authorisation of five new medicines, as well as one biosimilar drug and seven indication extensions. The full text is available here.
Positive recommendations for new drugs | ||
Drug | Company/organisation | Indication |
Daklinza (daclatasvir) | Bristol-Myers Squibb (BMS, US) | Treatment of chronic hepatitis C virus (HCV). |
Triumeq (abacavir sulfate + dolutegravir sodium + lamivudine) | ViiV Healthcare (UK) | Treatment and prophylaxis of human immunodeficiency virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg. |
Velphoro (mixture of polynuclear iron(iii)-oxyhydroxide, sucrose, and starches) | Vifor Fresenius Medical Care Renal Pharma (Switzerland) | Indicated for the control of serum phosphorus levels in patients with end-stage renal disease. |
Vizamyl (18F-flutemetamol) | GE Healthcare (UK) | Indicated for the visual detection of amyloid-beta neuritic plaques in the brain. |
Clopidogrel/acetylsalicylic acid Teva (clopidogrel + acetylsalicylic acid) | Teva (Israel) | Prevention of atherothrombotic events. |
Positive recommendation on biosimilar medicine | ||
Abasria (insulin glargine) | Eli Lilly (US) | Treatment of diabetes mellitus |
Positive endorsements for new therapeutic indications | ||
Avastin (bevacizumab) | Roche (Switzerland) | Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. |
Eliquis (apixaban) | BMS, Pfizer (both US) | Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. |
Enbrel (etanercept) | Pfizer | Non-radiographic axial spondyloarthritis. Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). |
Eylea (aflibercept) | Bayer (Germany) | Visual impairment due to diabetic macular oedema (DME). |
Isentress (raltegravir) | Merck & Co (US) | In combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children, toddlers, and infants from the age of four weeks.* |
Kalydeco (ivacaftor) | Vertex Pharmaceuticals (US) | Treatment of cystic fibrosis in patients age six years and older who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.* |
Stivarga (regorafenib) | Bayer | Unresectable or metastatic gastrointestinal stromal tumours (GIST) patients who progressed on or are intolerant to prior treatment with imatinib and sunitinib. |
Source: CHMP (*) Changes introduced to previous indications highlighted in bold. | ||
Outlook and implications
Among the decisions adopted by the CHMP, BMS's Daklinza has received the EMA's endorsement for marketing authorisation in the European Union for the treatment of chronic HCV infection in adults in combination with other therapies. The drug has demonstrated a high level of response when administered in combination with asunaprevir as a 24-week all-oral regimen treatment for genotype 1b HCV infections. In the Phase III HALLMARK-Dual trial, daclatasvir and asunaprevir showed that up to 90% of treatment-naïve patients achieved a sustained virologic response as 12 weeks (SVR12); 82% of non-responders to the peginterferon-ribavirin combination demonstrated an SVR12; 82% of patients ineligible or intolerant of the peginterferon-ribavirin combination; and 84% of cirrhotic patients (see BMS presents positive late-stage results for all-oral investigational HCV therapy). Furthermore, the drug is awaiting decisions for regulatory applications submitted in Japan and the United States. In particular, the US Food and Drug Administration granted all-oral Daklinza and asunaprevir combination therapy breakthrough therapy (BT) status in February (see United States: 25 February 2014: BMS's investigational daclatasvir/asunaprevir HCV combination regimen granted US FDA breakthrough status).
Furthermore, Eli Lilly and Boehringer Ingelheim (Germany)'s biosimilar insulin Abasria secured the CHMP's endorsement for marketing approval for diabetes patients in Europe. In particular, the drug is developed as a biosimilar version of Sanofi's best-selling drug Lantus (insulin glargine) and demonstrated a similar efficacy and safety profile as the originator (see Germany - United States: 19 June 2014: Eli Lilly, Boehringer report studies show similar safety, efficacy of biosimilar insulin glargine to originator). Lantus garnered revenues of EUR5.715 billion (USD7.803 billion) in full-year 2013 (see France: 6 February 2014: Sanofi sales decline by 5.7%, Genzyme and diabetes report double-digit growth). Sanofi will hold market exclusivity for Lantus in a majority of markets until May 2015; therefore, Abasria will probably be launched in Europe shortly after that date. Abasria is expected to challenge the current market share held by Lantus, as the biosimilar will likely be priced below the originator, putting significant pressure on current sales achieved by Sanofi.
Meanwhile, the CHMP has recommended marketing authorisation extensions of indications for a number of drugs, including cancer treatment Avastin (Roche), Bayer's ophthalmology treatment Eylea (aflibercept), and BMS and Pfizer's cardiovascular therapy Eliquis.
The decisions made by the EMA will be reviewed by the European Commission for final authorisation. The final decision from the European Commission on the marketing authorisation of a drug typically comes two months after the CHMP's recommendation. The European Commission's approval for commercialisation enables pharmaceutical companies to launch their products in the 28 EU member states as well as Iceland, Liechtenstein, and Norway.