Lundbeck's Acrescent is in serious danger of being denied access to the European market after the EMA's Committee for Medicinal products for Human Use declined to recommend the drug's approval for the treatment of Alzheimer's disease.
Acrescent is a combination of memantine hydrochloride and donepezil hydrochloride, which are separately approved within Europe, the former sold by Lundbeck as under the brand name Ebixa and the latter by Pfizer/Eisai as Aricept.
The Danish drugmaker is seeking regulatory clearance for the use of Acrescent to treat moderate to moderately severe Alzheimer’s disease, in patients already taking a daily dose of 20mg memantine and 10mg donepezil.
Explaining the decision, the Committee claimed that, overall, there was not enough data to show significant improvement in patients taking the combo treatment compared those taking memantine alone, and so it concluded that the benefits of Acrescent do not outweigh its risks.
Vivus' Qsiva (phentermine/topiramate) was also turned down for the treatment of obesity.
While studies indeed showed that clinically relevant weight loss following treatment with Qsiva, the Committee said it had concerns about the medicine’s long-term effects on the heart and blood vessels, the long-term psychiatric effects (depression and anxiety) and cognitive effects (including problems with
memory and attention).
Elsewhere, things were looking positive for Novo Nordisk's new diabetes drugs Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart).
Tresiba is a new basal analogue insulin for the treatment of diabetes mellitus in adults, which is widely expected to become a blockbuster with peak sales of more than $3 billion.
It comes in a pre-filled pen in two formulations - 100 units/ml and 200 units/ml - and if marketing authorisation is granted will become the first insulin to be approved in Europe at a higher strength than the standard 100 units/ml.
Weight gain, unhealthy diets and sedentary lifestyles have given rise to a growing trend of patients experiencing higher levels of insulin resistance and therefore needing higher doses of insulin to achieve glycaemic control, and so it is hoped that the availability of this new higher dose will help address a growing unmet need.
Ryzodeg is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart.
According to the CHMP, the benefits with Ryzodeg are "its ability to lower HbA1c, and a lower risk of nocturnal hypoglycaemia when compared with insulin glargine", and it said on the basis of the data submitted the product seems to have a favorable benefit-risk portfolio.
Also winning the Committee's favour, Astella's Betmiga (mirabegron) was recommended for approval for overactive bladder.