Zydus Lifesciences Secures USFDA Clearance for Duchenne Muscular Dystrophy Therapy

Pharma major Zydus Lifesciences Limited has got the final approval from the United States Food and Drug Administration (USFDA) for its filing to produce Jaythari (Deflazacort) Tablets. The approved strengths are 6 mg, 18 mg, 30 mg, and 36 mg, corresponding to the reference listed drug Emflaza Tablets.

This approval is a significant milestone for Zydus as it paves the way for its production of a key therapy for Duchenne Muscular Dystrophy (DMD). Deflazacort, which is a corticosteroid, is approved to treat DMD in patients five years and older. DMD is a serious genetic disorder that involves progressive muscle degeneration and weakness, primarily affecting male patients.

The production of Jaythari (Deflazacort) Tablets will be done at the plant of Doppel Farmaceutici S.r.l. in Italy. This global manufacturing facility will be used to serve the US market for this life-saving drug.

This new approval adds to Zydus Lifesciences' regulatory success, taking its approvals count to 424. The organization has also shown a persistent dedication to new drug applications, as it has submitted 492 Abbreviated New Drug Applications (ANDAs) since the fiscal year 2003-04.

This achievement comes hot on the heels of another USFDA approval accorded to Zydus for Apalutamide Tablets, which are employed in the management of metastatic castration-sensitive prostate cancer. These successes at the regulatory front highlight Zydus Lifesciences' resolve to broaden its portfolio of healthcare therapies across strategic markets globally.

In associated corporate action, Zydus Lifesciences recently made an announcement regarding the incorporation of a new step-down subsidiary, Zydus MedTech (France) SAS, on 10th April 2025. This subsidiary was created through its wholly-owned subsidiary, Zydus MedTech Private Ltd. Additionally, Zydus will be transferring its equity interest in Amplitude Surgical SA, a French entity in which it took a majority holding in March 2025, to this newly incorporated French subsidiary.

Investor reaction to the news of USFDA approval for Jaythari seems to be favourable. On Friday, Zydus Lifesciences shares saw a 2.90% rise in their closing value on the National Stock Exchange (NSE). The company has a high market capitalisation of ₹87,265.64 crore on the NSE as of 12th April 2025.

The approval of Jaythari represents a significant milestone for Zydus Lifesciences, providing access to a vital treatment for individuals living with Duchenne Muscular Dystrophy in the United States. This regulatory success, alongside the company's ongoing strategic corporate activities, positions Zydus for continued growth within the global pharmaceutical landscape.

Disclaimer: This is not a recommendation to buy or sell a stock. 

To read the RA disclaimer, please click here