Pharma regulatory news : Novartis has secured Egaten FDA approval for fascioliasis treatment in patients, aged six years and older.
Fascioliasis is a neglected tropical disease, commonly known as liver fluke infestation. The disease is said to affect millions of people across the world.
Fascioliasis is caused by two species of parasitic flatworms – Fasciola hepatica or Fasciola gigantic, which infect people after consuming larvae in contaminated water or food.
Egaten has become the only FDA-approved drug for Fascioliasis and the approval makes it easier to reach not only in the US but also in affected countries.
Commenting on Egaten FDA approval, Vas Narasimhan – CEO of Novartis said “Novartis has a long-standing commitment to addressing global health challenges and supporting disease elimination efforts, in diseases such as leprosy, malaria, and fascioliasis. Today’s FDA approval of Egaten is another important milestone that we believe will help further expand access to this one-day treatment, taking us a step closer toward disease elimination.”
Egaten is also the only drug for fascioliasis recommended by the WHO and is on the WHO Model List of Essential Medicines. WHO supplies the medicine during epidemic outbreaks as well as for periodic use in endemic countries.
With the Egaten FDA approval, drug licensing and import to the affected countries is expected to be enabled, thereby ensuring the adequate and prompt availability of the drug when required.
Novartis said that since 2005 it has been donating Egaten to the WHO, aiding in the treatment of about 2 million fascioliasis patients across 30 plus countries. The Swiss drugmaker has a renewed agreement with the WHO to extend the drug donation up to 2022 with the drug expected to be used for the treatment of 300,000 patients yearly.
Dr. Mwelecela Malecela – Director of the Department of Control of Neglected Tropical Diseases at the WHO, commenting on Egaten FDA approval, said: “This FDA decision is welcome news for millions who suffer or are at risk of fascioliasis and removes a major hurdle in expanding treatment to countries where it is most needed. We are thankful to Novartis for their sustained decade-long commitment in tackling yet another disease of poverty.”