A new diagnostic drug approved in the EU and China for the visualisation of colorectal lesions during colonoscopies.
Approved in the EU
The results of our Methylene Blue MMX® pivotal phase III study were announced in November 2016.
The primary endpoint, adenoma detection rate or ADR, was attained: adenomas were found in 56.3 % of all patients when they took methylene blue MMX® prior to the endoscopy procedure, compared to 47.8 % of all patients using standard of care white light colonoscopy with high definition endoscopes (relative difference between arms: 17.71%).
ADR is a key colonoscopy quality indicator and is defined as the % of patients undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed.
In the phase III clinical trial, the false positive rate (an important secondary endpoint) in the Methylene Blue MMX® arm was lower than in the WLHD. In the Methylene Blue MMX® arm, 356 subjects out of 485 subjects had an excision. Eighty-three of these subjects (23.3%) were false positives. In the WLHD arm, 326 out of 479 subjects had an excision and 97 of these subjects (29.7%) were false positives.
In February 2019, a Marketing Authorisation Application for Methylene Blue MMX® 200 mg tablets was filed with the European Medicines Agency. In August 2020, the European Commission approved Methylene Blue MMX® for the visualisation of colorectal lesions during colonoscopies.
Methylene Blue MMX® U.S.
Our New Drug Application (NDA) for Methylene Blue MMX® was submitted to the U.S. Food and Drug Administration (FDA) in July 2017. In May 2018, we received a Complete Response letter (CRL) from the F.D.A. The CRL stated that while the outcome of the phase III trial had translated in a statistically significant outcome, the outcome was not sufficiently ‘robust’ and recommended that we provide confirmation of effectiveness with a second phase III trial.
Discussions are ongoing with the FDA in relation to the confirmatory phase III trial required for U.S. registration.
Approved in China
The successful results of another phase III clinical trial of Lumeblue® in China conducted by partner China Medical System Holdings Limited (CMS) was announced in December 2022. The study was a randomized, double-blind, placebo-controlled trial (placebo being in this case the standard of care) run under GCP in 22 sites across China. The study met the primary endpoint with very high statistical significance.
The results demonstrated that Lumeblue® can significantly improve the detection rate of non-polypoid colorectal lesions (the primary endpoint of the study), leading to an improved detection rate of dangerous lesions such as non-polypoid adenomas (the secondary endpoint). In addition, Lumeblue® can be taken during the bowel preparation step, ensuring that colorectal staining is completed by the time colonoscopy is conducted. This not only enhances the detection rate of colorectal lesions but also potentially simplifies the colonoscopy procedure, making the examination more efficient and improving the screening benefits. Please refer to full details in the press release published here
Following the successful results, there was the territory expansion of the license agreement for Lumeblue® with China Medical System Holdings Limited announced in March 2023. The expansion goes beyond the existing licensed territories (Greater China including the mainland China, Hong Kong, Macao, and Taiwan) to include several countries belonging to the “Pan-Asia” region. Cosmo will continue to be the exclusive supplier of Lumeblue® also for these regions.
In June 2024, Lumeblue® received the approval for the innovative product in the territory by the National Medical Products Administration of China (NMPA) and on 18th June, CMS also obtained the corresponding Drug Registration Certificate.