DCGI approves AstraZeneca’s injection ‘Fasenra’ for treatment of severe eosinophilic asthma

The Drugs Controller General of India (DCGI) has approved an injection developed by AstraZeneca for the management of patients with severe eosinophilic asthma. Called Fasenra, the injection is to be administered once in eight weeks under the skin as an add-on maintenance treatment for patients 12 and older with severe eosinophilic asthma.

Studies have shown that treatment with Fasenra could significantly reduce oral steroid intake in these asthma patients, and thus reduce the potential steroid-related side-effects.

AstraZeneca India on Tuesday announced that it has received marketing authorisation from the DCGI for the launch of Fasenra in India, subject to other requisite regulatory approvals. Also Read – Working night shifts? You’re at high risk of severe asthma

The injection is designed to target cells in the body called eosinophils, which are a key cause of the eosinophilic subtype of asthma.

“The regulatory approval of Fasenra in India will provide better medicine for the management of eosinophilic asthma and support patients to attain a better quality of life,” Gagandeep Singh Bedi, Managing Director, AstraZeneca India, said in a statement, IANS reported.

Fasenra is currently approved as an add-on maintenance therapy for severe eosinophilic asthma in the US, EU, Japan and other countries. It is also approved for self-administration in the US and EU and other key markets.

Eosinophilic asthma: Things you should know about it

Asthma is an inflammatory disease of the airways, or bronchial tubes, that allows air to come in and out of the lungs. The narrowing and swelling of the airways, and excessive production mucus makes it hard to breathe and trigger coughing, a whistling sound (wheezing) when breathing out and shortness of breath.

Eosinophilic asthma (EA) is a type of asthma that is characterised by high levels of white blood cells, called eosinophils. These cells are a natural part of the body’s immune system and they fight infections and attack invading bacteria. However, in people with eosinophilic asthma, these cells cause inflammation and swelling in the airways and respiratory system. The severity of the asthma symptoms depends on the levels of eosinophils in the blood.

However, cases of eosinophilic asthma are rare. It is estimated that about 5 percent of all adults with asthma have EA.

Symptoms of EA are similar to the typical asthma symptoms, but there are a few symptoms that are more likely to occur in EA patients. These include –

shortness of breath
wheezing
chest tightness
coughing
obstructed airflow
chronic symptoms of sinus infections, such as stuffy nose, nasal drainage, and a reduced sense of smell
nasal polyps
higher than normal levels of eosinophils in the blood

Fasenra can reduce asthma exacerbations

A Phase IIIb trial of Fasenra (benralizumab) proved its efficacy in in severe eosinophilic asthma patients.

According to AstraZeneca, when added to standard of care, Fasenra injection demonstrated a 49% reduction in the annual rate of asthma exacerbation compared to placebo, in patients with baseline blood eosinophil counts higher than or equal to 150 cells per microlitre.

The drug also showed early improvements in lung function as well as improvements in asthma control, thereby improving health-related quality of life at week 24 compared to the placebo group.

In patients with chronic rhinosinusitis with nasal polyposis (NP), Fasenra also showed a clinically relevant improvement in symptoms.

Source: | This article originally belongs to thehealthsite.com

DCGI approves AstraZeneca’s injection ‘Fasenra’ for treatment of severe eosinophilic asthma

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DCGI approves AstraZeneca’s injection ‘Fasenra’ for treatment of severe eosinophilic asthma

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