EMA waves through a raft of drug recommendations
pharmafile | June 26, 2015 | News story | Research and Development, Sales and Marketing | AbbVie, Alexion, CHMP, EMA, Novartis, Novo Nordisk, brett wells
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended several treatments for marketing authorisation.
First up is Novartis with its multiple myeloma drug Farydak (panobinostat), which is the first cancer medicine that targets enzymes known as histone deacetylases or HDACs, which are involved in turning genes ‘on’ and ‘off’ within cells.
It is intended for patients with relapsed and/or refractory multiple myeloma who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. It is to be used in combination with bortezomib and the anti-inflammatory medicine dexamethasone.
The CHMP nod is based on a study of Farydak in combination with bortezomib and dexamethasone in 768 patients with multiple myeloma, 193 of whom had received at least two prior treatments that included bortezomib and an immunomodulatory agent.
Alessandro Riva who is the head of oncology at Novartis, says: “We are pleased with the positive CHMP opinion on panobinostat for previously treated patients because it brings us one step closer to providing a new treatment option for patients in need in Europe.”
The CHMP has also granted a positive opinion for AbbVie’s Humira (adalimumab) for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
HS is a painful, chronic inflammatory skin disease estimated to impact approximately 1% of the global adult population worldwide. AbbVie that now expects a decision regarding EC marketing authorisation during the third quarter, says this positive opinion represents progress toward the first and only approved medicine for HS.
Meanwhile Denmark’s Novo Nordisk has also been on the receiving end of good CHMP news in being issued with a positive opinion for the expanded use of Levemir (insulin detemir) for children with diabetes as young as one year old.
It now expects to receive marketing authorisation from the European Commission within two to three months.
Finally Alexion Pharmaceuticals will also be celebrating following a CHMP green light recommending marketing authorisation of its Strensiq (asfotase alfa) and Kanuma (sebelipase alfa).
The proposed indication for Strensiq is for long-term enzyme replacement therapy in patients with pediatric-onset hypophosphatasia to treat the bone manifestations of the disease.
For Kanuma the proposed indication is for long-term enzyme replacement therapy in patients of all ages with lysosomal acid lipase deficiency.
“The CHMP positive opinions for Strensiq and Kanuma are significant milestones in bringing these therapies to infants, children, and adults suffering from HPP and LAL-d in Europe,” says David Hallal, chief executive of Alexion.
Brett Wells
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