Glenmark US partner Salix gets USFDA nod for Crofelemer tablet
New Delhi: Drug firm Glenmark Pharmaceuticals on Wednesday said US health regulator has granted marketing approval to its US partner Salix Pharmaceuticals for Crofelemer tablets used for treating diarrhoea in HIV patients.
US Food and Drug Administration(USFDA) has provided marketing approval to its partner in US, Salix Pharmaceuticals, for Crofelemer 125 mg delayed-release tablets.
This is used for the symptomatic relief of non-infectious diarrhoea in patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy, the company said.
Commenting on the development, Glenmark Pharmaceuticals Chairman & MD Glenn Saldanha said: "The USFDA approval of Crofelemer for HIV associated diarrhoea will pave the wave to launch Crofelemer across our territories. This is a significant approval milestone and will enable the first NCE launch by Glenmark across emerging markets."
Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on anti-retroviral therapy (ART) who experience non-infectious diarrhoea, which often can lead to reduced treatment compliance, he added.
"Crofelemer, a locally-acting, minimally-absorbed drug is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss seen in HIV associated diarrhea...," Saldanha said.
Glenmark is the sole API supplier globally for Crofelemer (ex-China), the company said.
In addition, the Phase III study showed that Crofelemer did not influence the efficacy or safety of the patients HIV medications, it added.
The FDA approval of Crofelemer is based on "randomised, double-blind, placebo-controlled (one month) and placebo-free (five month) multi-centre study of 374 HIV-positive patients on ART, with a history of diarrhoea for one month or more," company said.
Data demonstrated that a significantly larger proportion of patients taking Crofelemer 125 mg twice daily experienced clinical response compared with patients in the placebo group, it added.
The most common adverse reactions in the study were respiratory tract infection, bronchitis, cough, flatulence, and increased bilirubin, the company said.
Meanwhile, in a filing to the BSE, Glenmark said it has received approval from the US health regulator for its generic Rizatriptan Benzoate tablets and it has commenced the shipping of the tablets immediately on the approval.
Shares of Glenmark Pharmaceuticals were today trading at Rs 538 per scrip on BSE, down 0.32 per cent from its previous close.