Arena Pharmaceutical Accepted By FDA For NDA
Arena Pharmaceutical achieves the approval of the Food and Drug Administration For New Drug Application; the release will provide patients with medication of chronic weight management treatment.
The drug manufacturer, Arena Pharmaceutical, has managed to receive the approval of the Food and Drug Administration of the United States for filing the New Drug Application (NDA). Through this extended release, the giant pharmaceutical company will now be able to formulate and give its patients treatment and medication for chronic weight management with once a day dosage.
The drug, Lorcaserin, will be manufactured with the approval for weight loss management. The biopharmaceutical company’s drug is manufactured and designed to aid obese and even overweight individuals with certain medical conditions, such as high cholesterol and blood pressure.
Lorcaserin is going to be sold by the name, Belviq, which will help the patients by decreasing their appetite and activating 2C receptors in the brain for more physical activity. However, it is not revealed that is this drug is healthy to consume with other prescribed medications or not, nor is it clear as to whether it will play any role in risks of a heart stroke or other heart diseases.
The pharmaceutical company’s senior vice president of operation and head of international regulatory affair, Craig M. Audet, said, “The filing of this application by the food and drug administration means they have made a threshold determination that it is sufficiently complete to permit a substantive review. This extended release formulation has the potential to offer patients once-daily dosing of Lorcaserin, which can be an important addition to their chronic weight management plan.”
Belviq is about to undergo two tests, one will be registration of clinical trials of 20 mg dosage and a twice each day 10 mg dosage. After this, the approved formulation will be marketed by the name of Belviq, and can be purchased and used by the patients from any pharmacy. This new medication is expected to be in high demand, as obesity has become a worldwide health problem.
After the approval, the medicine will help patients who have difficulty in losing weight through exercising and even dieting. Belviq XR version will enable consumers to simply take one dosage a day where previously they had to consume two. It will provide ‘convenience’, which the business was speaking about for a while now; thus, this version is not a surprise. Pregnant women cannot consume this medication, including the ones who are planning to get pregnant, nor nursing mothers.
Arena stock closed at $2.03 after going green by 4.64% on December 29, 2015.