GSK PLC on Wednesday announced progress in Japan on treating chronic hepatitis B and chronic rhinosinusitis with nasal polyps, while it welcomed a decision by the Delaware Supreme Court regarding heartburn drug Zantac.
The London-based pharmaceutical company said the Japanese Ministry of Health, Labour & Welfare has granted GSK’s Senku designation for bepirovirsen, an investigational antisense oligonucleotide for the treatment of hepatitis B. Antisense oligonucleotides are synthetic RNA or DNA sequences that bind to specific messenger RNA molecules via complementary base-pairing.
The designation is based on phase 2b trials which evaluated the efficacy, safety and durability of response of bepirovirsen in people with chronic hepatitis B, which affects about one million people in Japan and 257 million people worldwide.
It is GSK’s second designation for bepirovirsenm following the US Food & Drug Administration fast track designation in early 2024.
Further, the Japanese health ministry approved GSK’s mepolizumab, known as Nucala, for the treatment of adults with chronic rhinosinusitis with nasal polyps, a condition characterised by nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge. It is caused by chronic inflammation of the nasal lining that can cause soft tissue growth known as nasal polyps.
Mepolizumab is already approved in Japan for the treatment of bronchial asthma in children aged 6 and older, and in some adults with certain forms of asthma or forms of eosinophilic granulomatosis with polyangiitis, which is a rare form of vasculitis, characterised by inflammation within small blood vessels.
Finally, GSK welcomed the Delaware Supreme Court’s decision to review the Delaware Superior Court’s decision allowing the introduction of plaintiffs’ expert evidence at trial regarding heartburn drug Zantac, which had been pulled off the market in 2020 at the request of the FDA.
The Delaware Supreme Court will review the Delaware Superior’s Court decision according to the Daubert standard, which in the US provides criteria for evaluating whether expert testimony is admissible.
Zantac had been pulled off the market after low levels of a ‘probable carcinogen’ were found in samples. The carcinogen, known as NDMA, is not harmful in very small amounts. However, tests showed that there were excessive quantities of NDMA in ranitidine, otherwise known as Zantac. Multiple litigations have followed.
GSK said Wednesday: ‘The scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer. Since 2019, there are 16 epidemiological studies looking at human data regarding the use of ranitidine, including outcomes for more than 1 million patients using ranitidine, supporting this consensus.’
GSK shares were 1.6% higher at 1,644.00 pence each on Wednesday morning in London.
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