Ranbaxy Laboratories Limited (RLL), announced today that the company has received approval to manufacture and market Triviro-LNS kid and Triviro-LNS kid DS, both triple ARV combinations for children, in India. The company has also filed the product with WHO Geneva for pre-qualification.
While Triviro-LNS kid contains Lamivudine 20mg, Nevirapine 35mg, and Stavudine 5mg, Triviro-LNS kid DS contains the drugs in 40mg, 70mg and 10mg strengths respectively. The products are bio-equivalent with the individual liquid formulations of the originators. The products are indicated for treatment of HIV infection in children, a company release said.
"We hope that with these new formulations, we will be able to make accessible, a high quality and convenient treatment to a large number of HIV-positive children who are presently among the therapeutically most neglected," said Malvinder Mohan Singh, CEO and managing director, RLL. Presently HIV/AIDS kills about 500,000 children every year.
While convenient triple fixed dose combinations are widely available for adults, children have so far had to largely rely on cumbersome options such as simultaneously taking three different liquid ARV drugs or crushing and taking unpalatable adult triple drug formulations, an activity that does not deliver the three drugs in a ratio that is optimal for children. Most current options make compliance to therapy very difficult both for children and care-givers and may increase risk of resistance or adverse effects due to non- compliance.
Both the approved formulations are scored dispersible tablets, and are pleasantly flavoured. The products are designed to deliver three ARV drugs together in recommended strengths and simplify delivery of a more accurate treatment to children in resource poor settings.
Since 2001, Ranbaxy has been providing high quality ARV medicines, at affordable prices, to countries and patients afflicted by HIV/AIDS who might not otherwise have been able to gain access to this therapy. The Company's ARVs have been used as mainstays in various large treatment programs, both National and NGO/Institutional with good results. Ranbaxy is committed to supporting the global fight against HIV/AIDS through high quality, affordable medicines.
The Company presently has 12 ARVs on the WHO pre-qualification list of which three are US FDA approved.