CHMP in brief: Hospira’s Nivestim approved
pharmafile | March 22, 2010 | News story | Research and Development | EMA
A round-up of decisions from the Committee for Medicinal Products for Human Use (CHMP), including its recommendation for a chewable version of Lipitor for paediatric patients.
Pfizer’s anti-cholesterol blockbuster is also marketed as Sortis (atorvastatin calcium) and its paediatric formulation treats hypercholesterolaemia in children aged 10 years and upwards.
Following a paediatric investigation plan, the CHMP also recommended that this indication be approved for the currently available Sortis (film-coated tablets).
The decision was made under Article 29 of Regulation 1901/2006, which covers medical products for paediatric use: it allows companies to submit an application to the European Medicines Agency for a new indication or pharmaceutical form.
Meanwhile, after a review which began a year ago, the committee has given a positive opinion to Hospira UK’s Nivestim (filgrastim), a biosimilar of Amgen’s Neupogen.
The new version is for the treatment of neutropenia – an indication that Neupogen is already authorised in the EU.
Filgrastim regulates the production and release of functional neutrophils from the bone marrow.
The drug can be used to reduce the duration of the disease and the incidence of febrile neutropenia in patients who have been treated with cytotoxic chemotherapy for malignancy – other than chronic myeloid leukaemia and myelodysplastic syndromes.
It is also indicated for patients undergoing myeloablative therapy followed by a bone marrow transplant who are at risk of prolonged severe neutropenia.
In other decisions, the Committee has looked favourably on Roche’s application to extend the indication of Tarceva (erlotinib).
It will now include maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer who are stable after four cycles of standard chemotherapy.
The CHMP has also said yes to Apotex Europe’s Olanzapine Apotex (olanzapine), a generic of Lilly’s antipsychotic Zyprexa, authorised in the EU to treat schizophrenia.
Other generics to get the nod included Tolura (telmisartan), from Slovenian company Krka – a generic of Boehringer Ingelheim’s hypertension treatment Micardis – and Hospira’s Topotecan Hospira (topotecan).
This is a generic of GlaxoSmithKline’s Hycamtin, authorised for the treatment of carcinoma of the ovary and cervix and of small cell lung cancer.
Finally, the Committee reviewed more data on authorised pandemic influenza vaccines – Baxter’s Celvapan, Novartis’ Focetria and GSK’s Pandemrix.
It recommended changes to Celvapan’s product information to include more about the vaccine’s immunogenicity and safety.
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