The US Food and Drug Administration (FDA) has approved ANI Pharmaceuticals' supplemental New Drug Application (sNDA) for Purified CortrophinTM Gel for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), as well as excess urinary protein due to nephrotic syndrome.
"FDA’s approval of Cortrophin Gel enables us to bring a much-needed treatment choice to patients with acute exacerbations of multiple sclerosis and rheumatoid arthritis as well as nephrotic syndrome, who are coping with a devastating disease on a daily basis," said Nikhil Lalwani, President and Chief Executive Officer of ANI Pharmaceuticals. "We're excited to provide Cortrophin Gel, a proven medication, to give patients and prescribers another alternative. This approval underscores ANI's dedication to the patients and physicians we serve, as well as its development and manufacturing in the United States. By the first quarter of 2022, we expect a full-scale commercial launch."
"Patients who are refractory or intolerant to corticosteroids have an especially urgent need for effective alternatives and are at risk of ongoing organ damage with long-term disease," said Mary Pao Seideman, MD, PhD, ANI Pharmaceuticals' Chief Medical Officer" In
In the ACTH category, there has only been one treatment accessible for nearly 30 years. Patients will now have a crucial new therapy option thanks to the FDA's approval of Cortrophin Gel.
Cortrophin Gel was initially approved in 1954 and has been used to treat chronic autoimmune illnesses for decades. In 2016, ANI purchased the Cortrophin Gel NDA from Merck & Co. Over the last five years, the Company has made considerable investments in establishing and modernizing production processes as well as assuring a long-term, U.S.-based supply chain. In June 2021, ANI submitted a sNDA to the FDA to reintroduce Cortrophin Gel to the market for patients, providers, and a healthcare system in need of more ACTH medicines.
ANI is investing in and will create a patient support program, which will include financial help such as copay cards for qualified patients, as part of its commitment to ensuring optimal access to Cortrophin Gel. In connection with the commercial debut, more information on the program will be released.
ANI is currently up more than 22% jumping from $37.38 to approximately $46.
Contract manufacturing revenues increased by 10.7% to $2.4 million in the third quarter of 2021, ending September 30, 2021.
The increase was mostly attributable to a movement in the sales mix of consumers' sales toward higher average selling prices.