asthma

Sanofi has revealed that its interleukin-4 and interleukin-13 (IL-4 and IL-13) inhibitor Dupixent (dupilumab) has been awarded marketing approval by the European Commission as an add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO).

The decision follows a decision from the EC’s Committee for Medicinal Products for Human Use (CHMP) recommending the drug’s use back in March of this year.

Image Credit: NOMAD

Air pollution is linked to four million cases of childhood asthma each year, according to research published in The Lancet Planetary Health.

The researchers, from George Washington University, estimated that Nitrogen Dioxide (NO2) pollution was linked to 13% of all paediatric asthma cases diagnosed around the world each year.

This figure rose to 19% in the UK, as more than a fifth of childhood asthma cases in Britain were linked to NO2.

Happy Friday! With the weekend within reach, check out our run-down of the top ten most popular articles on Pharmafile.com this week, including Keytruda's liver cancer failure, a "game-changing osteoasrthritis treatment, AstraZeneca's retirement of the MedImmune brand, and the promise of the first new asthma pill in two decades.

10. Poland and Slovenia included in US-EU mutual recognition agreement

Researchers at the University of Leicester alongside colleagues in Vancouver, Canada, have revealed data that supports the efficacy of an investigational pill for the treatment of asthma. The oral, selective prostaglandin D2 receptor antagonist, known as Fevipiprant, is the first of its kind for two decades.

The therapy works by reducing the amount of smooth muscle in the ling of the airway, which can alleviate reduced airflow into the lungs and lowers the risk of asthma attacks.

Mylan’s Wixela has become the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler to be approved in the US.

The twice-daily therapy has secured marketing authorisation for the treatment of asthma in patients aged four years and older as well as the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

It’s good news for both asthma patients and AstraZeneca after UK drug watchdog NICE saw fit to recommend the drugmaker’s Fasenra (benralizumab) injection as a new option on the NHS in England and Wales for those living with severe forms of the disease.

The decision means that Fasenra becomes the third biological treatment available on routine use for the treatment of severe eosinophilic asthma, alongside GlaxoSmithKline’s Nucala (mepolizumab), recommended in December 2016, and Teva’s Cinqaero (reslizumab), recommended in October 2017.

Vectura has announced it is terminating development of its severe asthma therapy VR475, an inhaled formulation of the corticosteroid budesonide, after it failed in Phase 3 trials to demonstrate a significant impact on the condition.

Specifically, the therapy failed to show a reduction in the annualised rate of asthma exacerbations compared to placebo in severe asthma that is uncontrolled despite the use of high doses of inhaled steroids and a second controller medication. The drug was delivered via Vectura’s proprietary nebuliser.

Anglo-Swedish multinational AstraZeneca has agreed to sell the rights to three asthma and rhinitis drugs in a deal worth $350 million (£268 million).

The deal will see Swiss-headquartered and Luxembourg-listed firm Covis Pharma obtain rights to markets outside of the US as well as US royalties for all three medicines.

The sell-off has seen the company pursue a strategy of divestment and reinvestment as it develops new pipelines.

In yet more bad news for Teva, it has emerged that two of the firm’s late-stage studies in asthma have bombed, failing to meet their primary endpoints.

AstraZeneca has unveiled a double dose of approvals awarded to its medicines in Japan: Fasenra (benralizumab) has been given authorisation as an add-on treatment for severe asthma sufferers, while Lynparza (olaparib) has been given the go-ahead as a maintenance therapy in patients with ovarian cancer who responded to chemotherapy, regardless of BRCA mutation status.