[Photo by AMAG Pharmaceuticals]
Kwangdong Pharm announced on Monday it is preparing to launch Vyleesi, drug approved by U.S. Food and Drug Agency for treating hypoactive sexual desire disorder in women, in Korea. Kwangdong Pharm entered into a license agreement with U.S.-based Palatin Technologies in November 2017 for exclusive rights to develop and commercialize the drug in Korea.
Vyleesi, the trade name for bremelanotid, is the first FDA-approved product for the treatment of premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. Vyleesi often called Viagra for women will be available as a subcutaneous self-injection in a prefilled disposable autoinjector pen for use in anticipation of a sexual encounter.
In a phase 3 study of 1,267 premenopausal women diagnosed with hypoactive sexual desire disorder, Vyleesi demonstrated safety and effectiveness, according to Kwangdong Pharm.
Kwangdong Pharm is in talks with the Ministry of Food and Drug Safety over the process of a bridging study, a supplementary study on a particular medicine that is performed in the new region.
Kwangdong Pharm said it will file for marketing approval of the drug with the ministry in the third quarter of this year. The company the drug will be available in Korea from 2022.
AMAG, a US biopharmaceutical company, is responsible for making Vyleesi commercially available in September 2019.
After the FDA’s approval last month, the Washington Post reported that there is disagreement about whether drugs are the right approach because low sexual desire can be a result of numerous psychological, physiological or external factors, including stress.
By Kim Byung-ho and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]