MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has been granted approval for its proprietary product ArtemiC™ by the Food and Drug Authority (FDA) in the Kingdom of Saudi Arabia as an over-the-counter (OTC) dietary supplement.
The approval follows the success of Phase II clinical trials and European studies on the product’s effectiveness in assisting with the recovery of patients from COVID-19 and long-term COVID-19.
In 2022, MGC Pharma brought on board Capital Blossom Ltd, a specialist consultancy, as its representative in several key Middle Eastern markets. These include the Kingdom of Saudi Arabia, Sultanate of Oman, United Arab Emirates, Bahrain, Kuwait and Qatar.
Capital Blossom has been actively collaborating with its joint venture partner in Saudi Arabia to secure approval from the Saudi Food and Drug Authority.
Product validation
“We are delighted to receive Saudi FDA approval for ArtemiC™ which validates our product and follows the progress we had in USA earlier this year,” MGC CEO and managing director Roby Zomer said.
“We are hopeful this will materialise into commercial orders for MGC as we work closely with Capital Blossom Ltd who are specialists in this territory.”
About ArtemiC™
ArtemiC™, a product developed by MGC Pharma, has undergone clinical testing and features the innovative GraftBio® SNEDD technology. This technology enhances the bioavailability of the active components in ArtemiC™.
During a Phase II clinical trial, which was double-blind and placebo-controlled, ArtemiC™ was tested on 50 COVID-19 patients. The results highlighted several key benefits of ArtemiC™:
- It established a comprehensive safety and efficacy profile, with no adverse drug events reported.
- ArtemiC™ was effective in preventing the worsening of conditions in COVID-19 patients and contributed to faster clinical recovery.
- The product proved beneficial in alleviating symptoms and reducing pain associated with COVID-19.