Cipla gets CDSCO panel nod for BE study of idiopathic pulmonary fibrosis drug Pirfenidone
New Delhi: Pharmaceutical major, Cipla has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the single dose and multiple dose Bioequivalence Study (BE study) of Pirfenidone Extended Release Tablets 1200 mg, which is a novel antifibrotic oral agent used for the treatment of idiopathic pulmonary fibrosis.
This approval came when the drug-maker Cipla presented the proposal for manufacturing and marketing of Pirfenidone Extended Release Tablets 1200 mg along with single dose and multiple dose Bioequivalence Study (BE) study protocols.
Pirfenidone is a novel agent with anti-inflammatory, antioxidant, and antifibrotic properties. It may improve lung function and reduce the number of acute exacerbations in patients with idiopathic pulmonary fibrosis (IPF).
IPF is a rare and progressive respiratory disorder marked by the thickness and stiffening of lung tissue as well as the production of scar tissue. It's a form of chronic scarring lung disease that causes a steady reduction in lung function that's irreversible. Shortness of breath and a dry cough are two of the most common symptoms. Other symptoms include fatigue and unusually large, dome-shaped fingers and toenails. Pulmonary hypertension, heart failure, pneumonia, and pulmonary embolism are all possible complications.
Pirfenidone's exact mode of action and specific molecular targets are still unknown. The chemical, on the other hand, possesses anti-fibrotic, anti-inflammatory, and antioxidant properties. Suppression of TGF-1 (transforming growth factor-1), a major cytokine involved in fibrogenesis and extracellular matrix synthesis, is one key anti-fibrotic approach.
Pirfenidone 200 mg is available in India under the brands Pirfemac 200mg Tablet 10s from Macleods, Pirfenex 200 Mg Tablet 15s from Cipla, and Fibrodone 200mg Tablet 10s from Lupin.
At the latest SEC meeting for Pulmonary held on 31.08.2021 at CDSCO, the committee thoroughly examined the drug-maker Cipla's proposal for manufacturing and marketing of Pirfenidone Extended Release Tablets 1200 mg along with single dose and multiple dose Bioequivalence Study (BE) study protocols.
After detailed deliberation, the committee recommended the grant of permission to conduct the single dose and multiple dose Bioequivalence Study (BE) study as per the protocol presented.