JSE-listed pharmaceutical company Aspen has applied to the medicines regulator for the registration of the drug tirzepatide — used to treat type 2 diabetes — as a weight loss medication.
Without this approval the drug, marketed globally as Mounjaro, cannot be promoted as an aid to weight loss though it can be prescribed off-label by doctors for this. Tirzepatide has been registered in other countries for weight loss.
Registration approval by the SA Health Products Regulatory Authority (Sahpra) would bring Aspen’s product into competition with Novo Nordisk’s semaglutide Ozempic which was launched in SA about 18 months ago and has a local market value estimated at more than R400m.
Aspen senior executive Stavros Nikolaou said Ozempic had not been able to keep up with local demand given that there are more than 5-million diabetics in SA, not all of whom would need the product.
He noted that this class of drug was the fastest growing internationally and it was estimated that it would have a global value in the region of $150bn and $180bn by 2030. Novo Nordisk had become the biggest company in the EU due to Ozempic while US pharma giant Eli Lilly’s market capitalisation was about $900bn, largely driven by sales of tirzepatide.
Aspen announced on Friday that Sahpra had approved Mounjaro, the name under which Eli Lilly’s diabetes drug is marketed globally, for local use. The news saw a sharp spike in the Aspen share price.
“Mounjaro is a once-weekly glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, used as an adjunct to diet and exercise to treat adults with insufficiently controlled type 2 diabetes,” Aspen said.
Nikolaou said tirzepatide would be available in pharmacies from this week in the form of single-dose vials applied once a week with a KwikPen (a prefilled injection) presentation now under evaluation by Sahpra. He believed the medical aid schemes would fund a significant portion of the expense for the drug.
GLP-1s are a class of drugs originally developed for treating type 2 diabetes that are now increasingly used to treat obesity. They stimulate the pancreas to release insulin and suppress the release of the hormone glucagon, which help to control blood sugar levels in people with type 2 diabetes. They also act in the brain to reduce hunger, and delay the stomach from emptying so people feel full for longer.
Nikolaou pointed out that SA has experienced an explosion of type 2 diabetes, which is linked to obesity and which can, if left uncontrolled, lead to a number of cardiovascular and renal complications as well as impaired vision and impaired peripheral nerves.
He noted that 60-65% of females in SA were overweight and about 40-45% of males.
One in two diabetics in the country is undiagnosed and only present for diagnosis at a very late stage, he said.
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.