DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....
lorcaserin
may8, 2013
At long last, Eisai and Arena Pharmaceuticals have been given the go-ahead to launch their anti-obesity drug Belviq in the USA.
The US Food and Drug Administration approved Belviq (lorcaserin) last June chronic weight management in adults with a body mass index of 30 or greater, or adults with a BMI of 27 who have at least one weight-related condition such as hypertension, type 2 diabetes or high cholesterol. However, the agency said at the time that Belviq be classified by the US Drug Enforcement Administration as a scheduled drug, ie its potential for abuse needed to be evaluated.
This has held up a launch but now the DEA has placed Belviq into Schedule IV of the Controlled Substances Act, which means that the treatment has a low potential for abuse. In 30 days time, Eisai will make the drug available and the launch will trigger a $65 million milestone payment to Arena.
Arena will manufacture Belviq at its facility in Switzerland, and sell finished commercial product to Eisai for a purchase price starting at 31.5% of the Japanese drugmaker’s annual net product sales. The price increases on a tiered basis up to 36.5% exceeding $750 million and Arena is also eligible to receive $1.16 billion in purchase price adjustment payments.
Belviq can now compete against Vivus’ Qsymia (phentermine/topiramate) which was launched in September but has had disappointing sales, hit by reimbursement issues. Qsymia is also classed as Schedule IV by the DEA.
The move is clearly very good news for Arena which last week withdrew its marketing application for Belviq this side of the Atlantic. The European Medicines Agency’s Committee on Human Medicinal Products has expressed its concerns over potential cardiovascular risks and worries about tumours found in animal studies.www.arenapharm.com
Lorcaserin (APD-356, trade name upon approval Belviq, expected trade name during development, Lorqess) is a weight-loss drug developed by Arena Pharmaceuticals. It has serotonergic properties and acts as an anorectic. On 22 December 2009 a New Drug Application (NDA) was submitted to the Food and Drug Administration (FDA) in the United States. On 16 September 2010, an FDA advisory panel voted to recommend against approval of the drug based on concerns over both safety and efficacy. In October 2010, the FDA stated that it could not approve the application for lorcaserin in its present form.
On 10 May 2012, after a new round of studies submitted by Arena, an FDA panel voted to recommend lorcaserin with certain restrictions and patient monitoring. The restrictions include patients with a BMI of over 30, or with a BMI over 27 and a comorbidity like high blood pressure or type 2 diabetes.
On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for adults with a BMI equal to or greater than 30 or adults with a BMI of 27 or greater who “have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol”.
On 07 May 2013, the US Drug Enforcement Administration has classified lorcaserin as a Schedule IV drug under the Controlled Substances Act.
New Drug Approvals 
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