Isentress (raltegravir), a 600-mg film-coated formulation from Merck & Co., Inc. (NYSE:MRK) is likely to be approved. This is as a result of the positive opinions it is receiving from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The marketed drug, which has a recommended dosage is 1,200 mg is primarily used as a treatment for an HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
The CHMP positive opinion was based on findings from the ONCEMRK trial
Results from an ongoing Phase 3 active comparator-controlled clinical trial were used to evaluate and commend the efficacy of the ISENTRESS 1200 mg. This was being administered once daily and as a two 600 mg oral tablet. It was being compared to ISENTRESS 400 mg administered twice daily but the 1200mg demonstrated more power as an HIV-1 treatment regimen.
The results were encouraging according to the senior vice president, global clinical development; Merck Research Laboratories. “The CHMP’s positive opinion recommending the approval of ISENTRESS 600 mg film-coated tablets is an important step toward a new option for people living with HIV. ,” says Dr. Eliav Barr.
The formulation is now under review by the Food and Drug Administration and with the new unfolding, Merck hopes to have it approved in the second half of 2017.
ISENTRESS safety precautions
In 112 countries, Merck’s integrase inhibitor is approved as part of combination therapy. ISENTRESS chewable tablet, which must be in a combination therapy has also been approved in another 69 countries for use in children and adolescents with HIV-1 aged two years.
However, there are some precautions that must be observed given that there have been reported cases of severe and life-threatening fatal skin reactions from its use. It is strongly recommended to immediately discontinue its usage once potential reactions are noticed. On the other hand, ISENTRESS chewable tablets could also be unsafe to patients with phenylketonuria because they contain phenylalanine, which is a component of aspartame.
All said and one it is equally important to seek guidance from a physician on its usage. In the meantime, Merck’s stock was trading at $64.04 witnessing an increase of $0.26 or 0.41%.