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GSK’s Nucala gets boost with self-administration approval

Fasenra and Dupixent pose threat to leader


Nucala has received a boost in the eosinophilic asthma treatment market with a newly-approved autoinjector and a pre-filled safety syringe, allowing carers or patients to inject themselves.

The FDA approval makes Nucala the first anti-IL5 biologic to gain the approval - but rivals are hot on its heels, and could soon overtake it.

Nucala was first approved for use in severe eosinophilic asthma (SEA) in 2015, but is only now picking up momentum. The drug earned £152m ($193m) in Q1 this year (up 41% on the same period a year earlier) but is also facing competition from other IL-5 inhibitors including AstraZeneca’s Fasenra (benralizumab) and Teva’s Cinqair/Cinqaero (reslizumab).

Nucala must be administered every four weeks, and the new autoinjector and pre-filled syringe options will spare patients a trip to the doctors, once a health professional has agreed to it. This still leaves it at a disadvantage to Fasenra, which is administered just once every eight weeks.

Fasenra hits sales of $129m in the first quarter, suggesting AstraZeneca's drug could overhaul Nucala in the near future, and is expecting its own self-administration approval in the US and Europe in the second half of this year.

Another challenger is AZ and Amgen’s tezepelumab, which was awarded a breakthrough designation from the FDA for severe asthma last year.

Tonya Winders, president, Global Allergy and Asthma Patient Platform (GAAPP), added: “People living with conditions like severe asthma often struggle to control their day-to-day symptoms, making routine activities like attending healthcare appointments a challenge. Empowering patients to take their medicines at home is an approach that has been successful in other chronic diseases such as diabetes and rheumatoid arthritis. GAAPP welcomes this approval for Nucala so it can be administered in a doctor’s office or in the convenience of a patient’s home.”

Real world studies evaluating how patients used the self-administration devices found the vast majority successful after appropriate training, in both the autoinjector and pre-filled syringe (89-95% and 100% respectively).

The company has also just received recommendation from the EMA’s CHMP committee for the same use in Europe.

GSK had been hoping to extend Nucala's use significantly via an approval in COPD, but the FDA rejected its use in this setting last year, citing inadequate evidence of efficacy. This bad news has been tempered by disappointing results for AZ's rival Fasenra in the same setting.

Another significant challenger in the market is Sanofi's Dupixent, a dual IL-4 and IL-13 inhibitor, which has just gained European approval in eosinophilic asthma, adding to FDA approval gained in October.

Article by
Andrew McConaghie

7th June 2019

From: Sales



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