FDA approves Eisai’s chemo side-effects drug
pharmafile | October 15, 2014 | News story | Research and Development, Sales and Marketing | Eisai, FDA, Helsinn, akynzeo, chemotherapy, cinv
Eisai and Helsinn Healthcare’s Akynzeo (netupitant/palonosetron) has received FDA approval for the treatment of chemotherapy-induced nausea and vomiting (CINV).
CINV is one of the most common side effects of chemotherapy, and despite advances in treatments over the last few decades it still affects many patients. Akynzeo is a fixed combination pill consisting of palonosetron and netupitant which targets receptors associated with the condition.
Palonosetron, which is branded as Aloxi by the companies and was first approved by the FDA in 2008, prevents nausea and vomiting during the first 24 hours of chemotherapy, known as the acute phase.
New drug netupitant works during both the acute phase and the delayed phase, which is the period 25-120 hours after the start of chemotherapy where CINV is particularly prevalent.
The approval is based on data from Phase II and III clinical trials that tested the drug in both stages of chemotherapy for a variety of tumour types.
Akynzeo was found to be effective in 98.5% of patients treated during the acute phase, and 90.4% treated during the delayed phase. This is compared to 89.7% and 80.1% respectively for palonosetron alone.
Akynzeo is developed by Helsinn who will be promoting it in the US alongside Eisai, due to a licensing agreement between the companies signed back in 2010.
The approval will be a boost for Eisai, which has previously faced difficulties with the FDA surrounding its obesity drug Belviq (lorcaserin), marketed in partnership with the drug’s developer Arena.
Belviq was initially rejected by the FDA over safety concerns, and its entry to the market was delayed for several months even after approval. Eisai is now suing the FDA for allegedly deducting this time from the drug’s exclusivity window. All this could have affected sales, with Belviq making just $5.7 million in 2013.
Eisai and Helsinn will face competition in the CINV market from Merck’s Emend (aprepitant) however, which had global sales of $507 million in 2013 and is currently awaiting approval for use in children after promising trial results.
The two companies are also developing an injectable formulation of Akynzeo, and the EMA began assessment of the formulation in January 2014.
George Underwood
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