February 2015 meeting highlights of the Committee for Medicinal Products for Human Use

By William Chin, PhD, Project Manager, EUCRAF

Three new medicines have received recommendations for approval and 6 currently approved medicines have received recommendations on extensions of therapeutic indication from the Committee for Medicinal Products for Human Use (CHMP). This brings a total of 10 new medicines recommended for approvals and 11 positive opinions for extension of therapeutic indication for 2015. The meeting highlights from CHMP was published on the 27 February 2015. 

Medicine Active Substance MAH Opinion Indication
Jinarc tolvaptan Otsuka Pharmaceutical Recommendation for approval

Treatment of kidney disease

Zykadia ceritinib Novartis  Recommendation for approval

Treatment of anaplastic lymphomakinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)

Ristempa pegfilgrastim Amgen Recommendation for approval

Treatment of neutropenia

Adenuric febuxostat Menarini International Operations Recommendations on extensions of therapeutic indication

Prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome

Avastin bevacizumab Roche Recommendations on extensions of therapeutic indication

Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix

Humira adalimumab AbbVie Recommendations on extensions of therapeutic indication

Treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies

Soliris eculizumab Alexion Recommendations on extensions of therapeutic indication

Soliris is indicated in adults and children for the treatment of patients with paroxysmal nocturnal haemoglobinuria.Evidence of clinical benefit of Soliris is  demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history

Sustiva efavirenz Bristol-Myers Squibb Recommendations on extensions of therapeutic indication

Treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg

Vectibix panitumumab Amgen Recommendations on extensions of therapeutic indication

Treatment of adult patients with wild-type RAS metastatic colorectal cancer in first-line in combination with FOLFOX or FOLFIRI

Source

1. EMA, News and Press Release Archive, 27 February 2015, Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2015.