Drug major Cipla on Tuesday said it has received final approval from the United States Food and Drug Administration (USFDA) for Icatibant Injectable, indicated for treatment of acute attacks of hereditary angioedema – a rare genetic condition – in adults.
Cipla’s Icatibant injectable pre-filled syringe in the strength of 30mg/3mL is generic version of Shire’s Firazyr, the company said in a regulatory filing.
The firm said “it has received final approval for its abbreviated new drug application for Icatibant Injectable 30mg/3mL from the United States Food and Drug Administration”.
Quoting IQVIA (IMS Health) data, Cipla said Firazyr and its generic equivalents had US sales of approximately USD 270 million for the 12-month period ending May 2020. Shares of Cipla were trading 0.49 per cent higher at Rs 641.25 apiece on the BSE.
Earlier, Cipla Ltd had announced the launch of its generic version of remdesivir, which has been authorised by the USFDA for emergency use for the treatment of COVID-19 patients, under its brand name Cipremi
The USFDA had issued an Emergency Use Authorisation (EUA) to Gilead Sciences Inc for remdesivir for the treatment of COVID-19 patients.
Remdesivir is the only USFDA-approved EUA for treatment for adult and paediatric patients hospitalised with suspected or laboratory-confirmed coronavirus infection.
In May, Gilead Sciences Inc extended a voluntary non-exclusive licence to Cipla to manufacture and market generic version of remedisvir called Cipremi.
Cipla said it has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need.
Meanwhile, with 28,498 fresh cases recorded in a day, India’s COVID-19 tally sprinted past nine lakh on Tuesday, just three days after it crossed the eight-lakh mark, according to the Union health ministry data. The total coronavirus caseload in the country surged to 9,06,752 and the death toll mounted to 23,727 with 553 people succumbing to the disease in 24 hours, the data updated at 8 am on Tuesday showed.