Generex Biotechnology (Generex) has reported that the FDA has granted approval for its Oral-lyn under the FDA’s Treatment Investigational New Drug (IND) program.
Reportedly, the drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.
Under a structured Treatment IND protocol, Generex Oral-lyn will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available.
The company said that the Treatment IND will be open to eligible patients that comply with the inclusion/exclusion criteria of the protocol, including those who are taking approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.
Anna Gluskin, president and CEO, said: “We are excited about having the opportunity to meet the needs of American patients living with diabetes who have no satisfactory alternative treatment and have contacted the company, based on their special needs, about possible access to Generex Oral-lyn(tm).
“This opportunity to provide those in critical need of Generex Oral-lyn will continue while the pivotal phase III study concludes and the company prepares for its New Drug Submission with the USFDA and other major health authorities in key markets.”