News

A vaccine developed by GSK Plc to protect older adults against infection from the respiratory syncytial virus (RSV) has been approved in the US and given a positive opinion in the EU – the first such treatment to be approved anywhere in the world. The vaccine, Arexvy, will be launched in the US before the next RSV season which typically starts in the autumn and peaks in the winter. Launch in Europe is expected to follow a formal decision on marketing authorisation, which will be taken by the European Commission.

Eli Lilly and Co reported positive results for its Alzheimer’s disease drug donanemab on 3 May saying that the Phase 3 TRAILBLAZER-ALZ 2 trial met the primary and all secondary endpoints measuring cognitive and functional decline. The company expects to make a regulatory submission to the US Food and Drug Administration by 30 June. Lilly submitted a regulatory application for donanemab to the FDA in January but the agency turned it back citing insufficient data.

Astellas Pharma Inc is to pay $5.9 billion to acquire Iveric Bio Inc of the US giving it an ophthalmology asset under review at the US Food and Drug Administration. The asset, avacincaptad pegol, has been developed for geographic atrophy secondary to age-related macular degeneration. The FDA is expected to take a decision on marketing in August.

Health technology assessment (HTA) bodies in the US, Canada and the UK have reached a consensus about how confidential clinical data should be handled in their public assessments of new medicines. Each of the groups operates in a different healthcare environment, but they agree that more transparency is required in the future.

Roche, a company whose oncology portfolio traditionally drives sales, saw growth in the first quarter from several different therapy types. Although a decline in sales of Covid-19 products pulled revenue in the diagnostic division down, the pharma division continued to advance. Diagnostics had sales of CHF 3.6 billion, down by 31% in Swiss francs from a year earlier, but pharma had sales of CHF 11.7 billion, up by 5%. The sharp fall in diagnostic sales drove group sales down by 7% to CHF 15.3 billion ($17.1 billion).

Sanofi SA was further buoyed by its best-selling drug Dupixent in the first quarter as sales reached €2.3 billion and the path was cleared for a possible new indication in the US. The Food and Drug Administration is to review Dupixent for the treatment of chronic spontaneous urticaria, also known as hives. If approved, it would be the drug’s eleventh US indication since it was first approved for eczema in 2017.

US regulatory approval has been given to MaaT Pharma SA of France to start a Phase 3 trial of an experimental microbiome therapy in patients with graft-versus-host-disease, a potential complication from an allogeneic stem cell transplantation. The therapy, MaaT013, is an enema formulation consisting of samples of faeces from multiple healthy donors. The goal of the treatment is to restore gut microbiome diversity in order to help the body fight the disease.

The US Food and Drug Administration has approved the first oral microbiota product to prevent the recurrence of Clostridioides difficile (C. difficile) infection in individuals suffering repeat infection after treatment with an antibiotic. The product is made from human faeces. This is the second microbiota product targeting C. difficile infection to get a US approval in just five months. The first was a faecal transplant therapy developed by Ferring Pharmaceuticals Inc.

Novartis has raised its forecast for revenue growth in 2023 against a backdrop of double-digit sales increases for key cardiovascular, oncology and multiple sclerosis medicines. Group sales are now expected to grow by a mid-single digit figure, a mark-up from the previously forecast low-to-mid single digit increase. The Switzerland-based company also expects to complete the spin-out of Sandoz, its generics and biosimilar medicines business, before the end of the year.

AstraZeneca Plc expects revenue to increase by a low-to-mid single-digit percentage this year on the strength of its oncology portfolio and a continued penetration of the emerging markets. Revenue for the first quarter was $10.9 billion, unchanged from a year earlier at constant exchange rates, and down by 4% on a reported basis. While the US remains the company’s most important market, with sales of $4.3 billion in the quarter, the emerging markets including China were second, contributing $3.2 billion. China alone generated $1.6 billion or 15% of total group revenue.