The Drug Control Authority (DCA) has granted conditional approval for Tegrad (generic dolutegravir) for the treatment of the Human Immunodeficiency Virus (HIV), according to New Straits Times, a Malaysian news outlet.
Director-General of Health Tan Sri Dr. Noor Hisham bin Abdullah said the National Pharmaceutical Regulatory Division (NPRA), Ministry of Health Malaysia, evaluated the quality, safety and efficacy data on Tegrad and found it to be satisfactory for use in combination with other antiretrovirals in the treatment of HIV for patients aged 12 and above.
Tivicay is a brand name of dolutegravir, which has been approved by the U.S. Food and Drug Administration in August 2013. ViiV Healthcare received the FDA approval for the drug, which has been marketing the drug in 10 mg, 25 mg, and 50 mg dosages.
Tegrad is the first generic version of dolutegravir registered in Malaysia. It is a beneficiary of a Voluntary Licensing (VL) agreement between ViiV Healthcare and Medicines Patent Pool (MPP), an UN-backed international organization.
The agreement, which was signed in November 2020, has reportedly improved access to generic dolutegravir in four upper-middle-income countries – Malaysia, Azerbaijan, Belarus, and Kazakhstan.
Camber Laboratories holds the license and registration of generic dolutegravir in Malaysia.
“Efforts to enable Malaysia to be one of the countries that have access under the VL have been initiated by Health Ministry since 2014,” said Dr. Noor, who is also the President of Malaysia Medical Council (MMC).
“This is because at that time, access through VL to generic DTG products only involved use in the treatment of pediatric HIV patients only,” he added. “In 2015, the MOH began working with the MPP so that negotiations with patent holders also involved access to DTG generic drugs to treat adult HIV patients.”
Dr. Noor said, “The approval of this product [Tegrad] allows greater access to the drug at a more affordable cost, whether in public or private health facilities.”
“The ministry through National Pharmaceutical Regulatory Agency will continue to monitor and evaluate the latest data on quality, safety and effectiveness of DTG products, to ensure that the benefit-risk balance remains positive,” he added. “The ministry will also continue to be committed in its efforts to improve access to quality, safe and effective medicines for Malaysians.”
