European Medicines Agency recommends granting a marketing authorisation for lipegfilgrastim
Lipegfilgrastim is intended for prophylaxis against chemotherapy-induced neutropenia
On 30 May 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product lipegfilgrastim (Lonquex), 6 mg, solution for injection intended for prophylaxis against chemotherapy-induced neutropenia. The applicant for this medicinal product is Teva Pharma B.V. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
The active substance of Lonquex is lipegfilgrastim, an immunostimulating medicinal product (L03AA14) which regulates the production and release of functional neutrophils from the bone marrow.
The benefits with lipegfilgrastim are its ability to reduce the severity of neutropenia and the incidence of febrile neutropenia following the administration of myelotoxic chemotherapy. The most common side effects are musculoskeletal pains, thrombocytopenia, hypokalaemia, headache, skin reactions and chest pain.
A pharmacovigilance plan for lipegfilgrastim will be implemented as part of the marketing authorisation.
The approved indication is: "reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)".
It is proposed that lipegfilgrastim treatment be initiated and supervised by physicians experienced in oncology or haematology. Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for lipegfilgrastim and therefore recommends the granting of the marketing authorisation.