According to Tiziana Life Sciences, the FDA is allowing patients with multiple sclerosis who are taking part in an expanded access program through Brigham and Women’s Hospital to use intranasal foralumab at home instead of at the hospital. In April 2022, the company announced that the agency had agreed to allow the access program to expand to a total of 10 patients who receive 50 μg of intranasal foralumab 3 times per week.
The company says that it has agreed with the FDA on materials to train patients to use the nasal delivery device, and patients will now be required to appear in-person at the clinic once every 3 weeks instead of 3 times per week. Additionally, Tiziana says that an upcoming Phase 2a trial of intranasal foralumab in non-active secondary progressive multiple sclerosis patients will use the same schedule.
Tiziana Chief Development Officer William A. Clementi said, “Since the beginning of the na-SPMS EA program, patients have been going to the MS clinic at Mass General Brigham to receive their 3 times a week dosing. Now, these patients will only need to go to the clinic once every 3 weeks. This dosing and medical evaluation schedule will also be mirrored in our Phase 2a double-blind study, which is due to start in November.”
Chairman and acting CEO Gabriele Cerrone commented, “Traditionally, MS patients have had to visit healthcare facilities for treatment, which could be inconvenient and burdensome. The FDA’s approval for home dosing of foralumab will transform the way patients manage their condition, offering them greater control over their treatment schedules and the convenience of receiving care in their familiar environment. We are elated with the FDA’s allowance for home dosing of intranasal foralumab. This step significantly aligns with our mission to make innovative therapies more accessible to patients and ultimately improve their quality of life. We believe that this treatment approach will revolutionize the way multiple sclerosis patients manage their condition.”
Read the Tiziana Life Sciences press release.
