Positive CHMP verdicts for Actelion and Lundbeck
pharmafile | October 28, 2013 | News story | Sales and Marketing |Â Â Actelion, CHMP, FDA, LundbeckÂ
Actelion and Lundbeck both took a step closer to EU approval for two drugs seen as pivotal to their future fortunes late last week.
The latest set of opinions from the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) included recommendations for Lundbeck’s antidepressant Brintellix (vortioxetine) and Actelion’s Opsumit (macitentan) for pulmonary arterial hypertension (PAH).
Both of the products are being positioned to replace big-selling older drug products that are facing generic competition.
In the case of Opsumit, the drug is a follow-up to the Swiss biotech’s blockbuster PAH treatment Tracleer (bosentan), which goes off-patent in 2015 and is by far its biggest earner, accounting for 1.13 billion Swiss francs out of Actelion’s total 1.32 billion francs in the first nine months of the year.
Opsumit was approved by the US Food and Drug Administration earlier this month, becoming the first drug for PAH to be approved on the back of biomarkers rather than clinical outcomes such as the six-minute walking test (6MWT).
Unlike Tracleer, the new drug does not require patients to be monitored for liver enzyme levels, a feature which has helped sales of another PAH drug in the same endothelin antagonist class – Gilead Sciences’ Letairis (ambrisentan) – leap forward 30% to $246 million in the first six months of 2013. Opsumit has been tipped to achieve peak sales of $1.4 billion or more by some analysts.
Meanwhile, the CHMP also backed Brintellix for treating major depressive episodes in adults, taking Lundbeck closer to securing EU approval for the replacement to its former blockbuster Cipralex/Lexapro (escitalopram) which has already lost patent protection in some of its biggest markets, including the US.
Brintellix has a different mode of action to its predecessor, working as a serotonin 5-HT3 and 5-HT7 receptor antagonist, and 5-HT1b receptor partial agonist, and 5-HT1a receptor agonist as well as an inhibitor of the serotonin transporter SERT, and is described as the first novel drug treatment for depression since 2007.
The product was also granted approval in the US, where it will be co-promoted with Takeda. Analysts have said it could reach sales of $500 million within three years and $1.5 billion at peak.
Other opinions
In other developments, the CHMP also issued a positive opinion on Hospira’s generic version of UCB’s anti-epileptic Keppra (levetiracetam) and said the label for UCB’s immunological therapy Cimzia (certolizumab pegol) should be expanded to include psoriatic arthritis as well as its existing uses in rheumatoid arthritis, Crohn’s disease and axial spondyloarthritis.
It also said Laboratoires Biocodex’ orphan drug for severe myoclonic epilepsy in infancy (SMEI) – Diacomit (stiripentol) – should be switched from conditional to full marketing approval.
Phil Taylor
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