Merck & Co won US approval to expand the use of its anti-nausea drug Emend yesterday, which could add sales momentum to a product that has taken a while to get going.
Emend (aprepitant), which is used to prevent nausea in patients undergoing chemotherapy for cancer but is ineffective once symptoms are already established, is now approved for use with other anti-emetic medicines in initial and repeat courses of moderately emetogenic chemotherapy.
The drug was first approved in 2003, but only for use in highly-emetogenic chemotherapy regimens, such as those including high-dose cisplatin. The new indication should broaden the patient population eligible to receive Emend significantly, according to Merck.
Merck reported sales for Emend of $59 million dollars in the first nine months of 2005, more than double the amount garnered by the product a year earlier.
Approval was based on the findings of a study published in April 2005 in the Journal of Clinical Oncology which compared a regimen including of Emend in combination with GlaxoSmithKline’s Zofran (ondansetron) and dexamethasone to ondansetron and dexamethasone alone.
Adding Emend to the regimen raised the proportion of patients suffering no nausea and vomiting and needing no other anti-emetic therapies to 51% from 42% in the control group.
– Meanwhile, Merck has confirmed that the date for the fourth drug liability trial for withdrawn painkiller Vioxx (rofecoxib) is January 24. It will be held in Texas and look at the case of Leonel Garza, a 71-year-old who died from a heart attack after taking Vioxx for a week in 2001.
The first federal case involving the drug, which ended in a hung jury last month, will be re-tried in a New Orleans court in February.
