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On Wednesday, GSK (LSE:GEK) announced several significant updates. The company welcomed a decision from the Delaware Supreme Court to review a lower court ruling that permitted the introduction of expert evidence in ongoing litigation related to its former heartburn drug, Zantac (ranitidine).
The pharmaceutical giant viewed the interlocutory review, granted under exceptional circumstances, as a favorable development in its defense against allegations that Zantac could increase cancer risk. GSK highlighted that the scientific consensus, supported by 16 epidemiological studies involving over a million patients, did not establish a reliable link between ranitidine and cancer.
In addition, GSK revealed that its monoclonal antibody, Nucala (mepolizumab), received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Nucala, which targets interleukin-5 (IL-5), is now the first and only biologic in Japan to offer a four-weekly dosing schedule for this condition. This approval represents the third indication for Nucala in Japan for an IL-5 mediated condition, providing a non-surgical treatment option for patients who have not responded to standard therapies.
Furthermore, GSK announced that its investigational antisense oligonucleotide, bepirovirsen, had received SENKU designation from the MHLW for the treatment of chronic hepatitis B (CHB). This designation, aimed at accelerating the review process for innovative treatments addressing serious conditions, follows the earlier Fast Track designation by the US FDA. The SENKU designation was based on promising data from the phase IIb ‘B-Clear’ and ‘B-Sure’ trials, which indicated bepirovirsen’s potential to achieve a functional cure for CHB, a condition affecting millions globally, including nearly one million people in Japan. GSK noted that bepirovirsen is the only single agent in phase three development showing potential for a clinically meaningful cure when combined with oral nucleoside/nucleotide analogues (NAs).
At 0830 BST, GSK’s shares were up 1.4% at 1,641.5p.
