Aristospan (triamcinolone hexacetonide) — a treatment for juvenile idiopathic arthritis (JIA) and similar disorders — has been approved for public reimbursement in Canada, after the completion of price negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA).
The commercial launch — expected to roll out over the coming months — will make Medexus Pharmaceuticals‘ product available for children and adults with many forms of joint disease, who for long could not get the therapy due to a shortage.
“Public reimbursement marks an important milestone for the company,” Ken d’Entremont, CEO of Medexus, said in a press release. “[C]hildren and adult patients suffering from debilitating forms of joint disease now have a reliable source and greater access to TH [triamcinolone hexacetonide].”
TH, Aristospan’s active ingredient, is an injectable corticosteroid first marketed in Canada by Riemser Pharma (now part of Esteve), under the brand name Lederlon. But after problems in its manufacturing facility, the company ended up discontinuing Lederlon in 2014.
A subsequent shortage across Canadian provinces led Medexus to approach Riemser, and establish a partnership to distribute TH. The two companies filed for approval in late 2016.
Health Canada agreed that Aristospan could treat adults and adolescents with JIA, rheumatoid arthritis, osteoarthritis, and post-traumatic arthritis, as well as for those with inflammation in the synovial membrane (synovitis), tendons (tendinitis), fluid-filled sacs in the joints (bursitis), or in the elbow (epicondylitis). Its approval decision came in December 2017.
“TH transforms the treatment of many severe joint diseases as it provides a longer duration of action, with fewer injections, compared to other corticosteroid injections and intra-articular steroids,” d’Entremont said.
“By reducing the number of injections, we believe TH offers a safer and more cost-effective solution for the healthcare system, by reducing the number of hospital visits and need to put pediatric patients under general anesthetic for these injections,” he added.
Medexus has been providing Aristospan to children with JIA within Canada’s Special Access Program — which provides access to unmarketed drugs for serious or life-threatening conditions — since October 2018. Aristospan’s commercial launch will now make it available also to adults.
The company is also planning to bring Aristospan to other countries and territories, including the United States, where TH is also in shortage, d’Entremont said in a video interview with Proactive Investors.
“We are currently shipping it to patients in the U.S. through the personal importation program,” and “working with the FDA [U.S. Food and Drug Administration] to find a way to permanently solve the problem,” he added.