GSK upbeat on Zantac litigation development, Japan approvals

The FTSE 100 pharmaceuticals giant said the interlocutory review, granted under exceptional circumstances, was seen as a positive step, as it continued to defend itself against claims that its now-discontinued heartburn drug increased cancer risk.

GSK emphasised 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 a separate development, GSK announced that its monoclonal antibody, ‘Nucala’, or mepolizumab, had been approved by Japan's Ministry of Health, Labour and Welfare (MHLW) for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP).

Nucala, which targets interleukin-5 (IL-5), was now the first and only biologic in Japan with a four-weekly dosing schedule for this condition.

The approval marked the third indication for Nucala in Japan for an IL-5 mediated condition, offering a non-surgical option for patients who have not responded to standard treatments.

Finally, GSK said its investigational antisense oligonucleotide, ‘bepirovirsen’, had received SENKU designation from the MHLW in Japan for the treatment of chronic hepatitis B (CHB).

The designation, aimed at expediting the review process for innovative therapies addressing serious conditions, followed the US FDA's Fast Track designation earlier in the year.

It said the SENKU designation was based on promising data from the phase IIb ‘B-Clear’ and ‘B-Sure’ trials, which demonstrated bepirovirsen’s potential to achieve a functional cure for CHB, a condition affecting millions worldwide, including nearly one million people in Japan.

GSK said Bepirovirsen is the only single agent in phase three development that had shown potential for a clinically meaningful cure when combined with oral nucleoside/nucleotide analogues (NAs).

At 0830 BST, shares in GSK were up 1.4% at 1,641.5p.

Reporting by Josh White for Sharecast.com.