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Nucala

European approval for two new delivery formulations of GSK's Nucala in severe eosinophilic asthma

Following closely on the heels of the news that its deal to merge Pfizer’s consumer health business with its own, GSK has announced that Nucala (mepolizumab) had secured approval from the European Commission for two new delivery methods for patients with severe eosinophilic asthma to self-administer.

The drug, which is the only monthly anti-IL5 biologic approved in Europe, was authorised in a pre-filled pen and a pre-filled safety syringe form, based on Phase 3a data from two real-world studies which indicated that 98% of patients and 100% of caregivers were able to successfully ad

GSK's Nucala data insufficient for US COPD approval

GlaxoSmithKline has suffered a regulatory blow in the label expansion of its interleukin-5 (IL5) inhibitor Nucala (mepolizumab), with the FDA rejecting the application for the drug’s use in the maintenance treatment for the reduction of exacerbations in coronary pulmonary obstructive disorder (COPD).

GSK confirmed that its inhaled corticosteroid-based maintenance treatment was knocked back due to requests submitted in a clinical response letter for more clinical data to support an approval, a request which the company has confirmed it is working closely with the US regulator to ach

AZ’s hopes for Fasenra in COPD suffer terminal blow

It looked unlikely that Fasenra would achieve success in the chronic obstructive pulmonary disease (COPD) area, after it suffered in trial results released earlier this month.

AstraZeneca has now released the results from the second trial into the area and they only confirm the company’s fears, the treatment is a dud for COPD.

The short press release simply states that the trial did not meet its primary endpoint of reducing exacerbations and, perhaps coming as no surprise, would not be pursuing a regulatory submission any time soon.

AZ’s Fasenra stumbles in P3 for COPD

AstraZeneca’s Fasenra arrived later on the scene than GSK rival med, Nucala, and so it needed to quickly rack up indications to mount a serious challenge – in COPD, at least, that looks more unlikely after the treatment wasn’t able to meet its primary endpoints in a Phase 3 trial.

Fasenra is already approved to treat severe eosinophilic asthma in major markets around the world but was hoping to add to this with an expansion into treating exacerbations in those with moderate to very severe COPD.

NICE recommends GSK's "first-in-class" asthma drug

NICE has announced its recommendation of GSK’s “first-in-class” biologic Nucala (mepolizumab) as an extra option for the treatment of adults suffering from severe forms of asthma.

GSK’s Nucala gets regulatory approval in Japan to treat bronchial asthma

GlaxoSmithKline (LSE: GSK) on Tuesday said the Japanese regulators have approved its drug to treat bronchial asthma. 

The Japanese Ministry of Health, Labour and Welfare has granted approval for Nucala (mepolizumab), which is licensed in Japan for adults and adolescents aged 12 years or older, the company said. 

GSK says long-term study for Nucala backs safety profile

UK pharma major GlaxoSmithKline (LSE: GSK) said its asthma drug, Nucala (mepolizumab) showed a similar safety profile in a long-term study compared with previous studies.

The drug is already approved in the US and Europe.

Researchers question price of GSK’s Nucala

Nucala

GSK is charging up to four times more for its recently approved asthma drug Nucala than is justified by cost-effectiveness thresholds, an influential US health economic analysis group has concluded in a new report.

Nucala (mepolizumab), which was approved last month by the FDA, is a once-monthly injectable drug used to treat severe asthma, which in the US costs $32,500 for a year’s course of treatment.

GSK gets European approval for asthma treatment Nucala

GlaxoSmithKline has received marketing authorisation from the European Commission for Nucala as an add-on treatment for severe refractory eosinophilic asthma in adult patients.

The European approval follows GSK’s announcement yesterday that Nucala (mepolizumab) is now also available by prescription in the US. The FDA approved the treatment for the same indication November 4.

GSK asthma drug Nucala gets FDA approval

GlaxoSmithKline has received approval from the FDA for Nucala as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, who have an eosinophilic phenotype.

Nucala (mepolizumab) is now approved for patients who have a history of severe asthma attacks (exacerbations), despite receiving their current asthma medicines. 

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