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(Alliance News) - AstraZeneca PLC said Monday that the Melody Phase III trial for nirsevimab met its primary endpoint.
The pharma giant also noted its Tagrisso and Selumetinib treatments have been recommended for use in the EU.
Nirsevimab is a long-acting antibody, which is being developed by Astra and Sanofi SA. It is used to treat respiratory syncytial virus.
It is the first potential immunisation to show protection against RSV in the general infant population in a Phase III trial, Astra explained.
"Preliminary analysis of the safety profile for nirsevimab was consistent with previous trial data. No clinically meaningful differences in safety results between the nirsevimab and placebo groups have been seen," Astra added.
Mene Pangalos, executive vice president, BioPharmaceuticals Research & Development, said: "These ground-breaking results mark a major scientific advancement in our effort to provide protection against respiratory syncytial virus for all infants.
"Nearly all children will contract the virus before age two, leading to nearly 30 million acute lower respiratory tract infections globally each year. Nirsevimab has the potential to provide a significant public health benefit as the first respiratory syncytial virus immunisation for the general infant population, and these data bring us one step closer to delivering nirsevimab to infants worldwide."
Nirsevimab also is being evaluated in the Phase II/III Medley trial which will assess the safety and tolerability of nirsevimab compared to Synagis among pre-term infants and children with chronic lung disease and congenital heart disease entering their first and second RSV seasons. The Phase II/III trial is expected to complete early with first data anticipated in the coming months.
Nirsevimab has been granted breakthrough designation by the regulators in China, the US and Europe.
Turning to Selumetinib, which Astra is developing alongside Merck & Co Inc, it has been recommended for conditional marketing authorisation in the EU for the treatment of symptomatic, inoperable plexiform neurofibromas in paediatric patients with neurofibromatosis type 1 aged three years and above.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from SPRINT Stratum 1 Phase II trial.
The trial showed selumetinib demonstrated an objective response rate of 66% in paediatric patients with NF1 PN when treated with selumetinib as twice-daily oral monotherapy.
Finally, Astra also said its Tagrisso treatment for patients with early-stage EGFR-mutated lung cancer has been recommended for approval in the EU by CHMP.
If approved, Tagrisso will be indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 mutations, Astra said.
Dave Fredrickson, executive vice president, Oncology Business unit, said: "With no targeted treatment options currently available for early-stage lung cancer patients after surgery in the EU, recurrence rates remain unacceptably high. This positive recommendation is a vital step towards introducing a targeted treatment option for these patients for the first time. It also reinforces the urgency to test all lung cancer patients for tumour mutations before making any treatment decisions to ensure that as many patients as possible can benefit from innovative therapies, like Tagrisso, when they become available."
Shares in AstraZeneca were down 0.1% in London on Monday morning at 7,557.00 pence each. Sanofi was 0.3% higher in Paris at EUR85.60, while Merck ended Friday's session in New York at USD77.88, down 0.1%.
By Paul McGowan; paulmcgowan@alliancenews.com
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