Mumbai, Jun 20 () AstraZeneca Pharma India today said it has received marketing authorisation from the Drug Controller General of India (DCGI) for Symbicort, a medicine used for treatment of asthma.
“We have received marketing authorisation from the Drug Controller General of India (DCGI) for Symbicort 320 mcg. It is a fixed-dose combination drug comprising budesonide and formoterol fumarate dehydrate delivered through a special device.
“It is indicated for treatment of severe asthma and for patients with moderate to severe chronic obstructive pulmonary disease (COPD) with frequent symptoms and a history of exacerbations,” a company statement said here.
Symbicort is approved for use in 91 countries for treatment of asthma and COPD.
Results from AstraZeneca’s two major clinical studies have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbation, the statement said.
Similarly, in two 12-month studies in patients with COPD, Symbicort was superior to placebo, formoterol and budesonide regarding lung function and showed a significant reduction in the exacerbation rate compared with placebo and formoterol, it said.
“Asthma and COPD are common and major causes of chronic morbidity impacting millions of patients in India. It is often not well controlled by existing treatments. Symbicort will offer physicians and patients another treatment option for severe asthma and for moderate to severe COPD,” said Anilda D’souza, a senior executive of AstraZeneca India.
Asthma is a common and chronic condition that affects the lungs’ airways. Inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. AP RSY