Three new drugs have been recommended for approval in the European Union by the European Medicines Agency's Committee for Medicinal Products for Human Use in its July meeting. The committee has also recommended for approval one biosimilar drug.
IHS Life Sciences perspective | |
Significance | The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has released positive opinions for marketing authorisation in Europe for three drugs. The committee has also recommended approval for one biosimilar drug and seven drugs for extended indications. |
Implications | In particular, the CHMP has recommended for approval two leukaemia treatments, namely Janssen's Imbruvica and Gilead's Zydelig. Novo Nordisk's type 2 diabetes drug Xultophy has also received the CHMP endorsement. Finally, a new biosimilar drug may soon reach the EU market, as Accord Healthcare's Accofil has been recommended for approval. |
Outlook | The recommendations issued by the CHMP will be now sent to the European Commission for a final decision. The final opinion from the European Commission generally comes two months after the CHMP decision. If the European Commission grants marketing authorisation, the drugs will be commercialised throughout the 28 EU member states and Iceland, Liechtenstein, and Norway. |
The European Medicines Agency's Committee of Medicinal Products for Human Use (CHMP) issued on 25 July positive opinions for approval of three new drugs in the European Union, as well as one biosimilar drug and seven medicines' indication extensions. The full text is available here.
Positive recommendations for new drugs | ||
Drug | Company/organisation | Indication |
Imbruvica (ibrutinib) | Janssen-Cilag (subsidiary of Johnson & Johnson, US) | Treatment of relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia (CLL). |
Xultophy (insulin degludec + liraglutide) | Novo Nordisk (Denmark) | Treatment of type 2 diabetes mellitus. |
Zydelig (idelalisib) | Gilead Sciences (US) | Treatment of patients with CLL and patients with refractory follicular lymphoma. |
Positive recommendation on biosimilar medicine | ||
Accofil (filgrastim) | Accord Healthcare (UK) | Treatment of neutropaenia |
Positive endorsements for new therapeutic indications | ||
Baraclude (entecavir) | Bristol-Myers Squibb (US) | Baraclude is also indicated for the treatment of chronic HBV infection in nucleoside-naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients. |
Busilvex (busulfan) | Pierre Fabre (France) | Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor-cell transplantation in adult patients who are candidates for a reduced-intensity conditioning regimen. |
Ecalta (anidulafungin) | Pfizer (US) | Treatment of invasive candidiasis in adult patients. |
Humira (adalimumab) | AbbVie (US) | Enthesitis-related arthritis. Humira is indicated for the treatment of active enthesitis-related arthritis in patients, six years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. |
Ozurdex (dexamethasone) | Allergan Pharmaceuticals (US) | Visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. |
RoActemra (tocilizumabum) | Roche (Switzerland) | The treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. |
Xgeva (denosumab) | Amgen (US) | Treatment of adults and skeletally mature adolescents with giant-cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. |
Source: CHMP | ||
Outlook and implications
Among the opinions published in its July meeting, the CHMP has backed two new treatments for leukaemia: Janssen's Imbruvica and Gilead Sciences' Zydelig, both targeting CLL, a major unmet disease in Europe. Approximately 3 in 10,000 people suffer from CLL in Europe and 3.7 in 10,000 people from follicular lymphoma. Whereas in the US Imbruvica reached the market before Zydelig, in Europe the two drugs are on track to receive EU approval at the same time.
In particular, the US FDA breakthrough therapy-designated product Imbruvica, developed in partnership with Pharmacyclics (US), was approved in the US as a second-line treatment of CLL and mantle-cell lymphoma (see United States: 13 February 2014: US FDA approves J&J, Pharmacyclics' Imbruvica for CLL and United States: 14 November 2013: J&J's breakthrough ibrutinib receives US FDA approval, faces setback with hip replacement settlement). In addition, application supplemental New Drug Application for Imbruvica for the treatment of patients with CLL and small lymphocytic lymphoma (SLL) was accepted by the FDA in June (see 11 June 2014: United States: Pharmacyclics, J&J's Imbruvica receives priority review for CLL and SLL).
Zydelig, a PI3k inhibitor, was approved by the US FDA on 23 July in combination with Roche (Switzerland)'s MabThera/Rituxan (rituximab) for patients with relapsed CLL and as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma and SLL who have received at least two prior systemic therapies.
Type 2 diabetes drug Xultophy (insulin degludec + liraglutide) was recommended including a pharmacovigilance plan, and the CHMP also backed approval of a new biosimilar, Accord Healthcare's filgrastim medicine Accofil.
The positive recommendations provided by the CHMP pave the way for the drugs to receive final approval from the European Commission. The European Commission usually adopts a final decision two months after the CHMP recommendation. Final approval for commercialisation enables companies to roll out their treatment in the 28 EU member states as well as Iceland, Liechtenstein, and Norway.