8 months ago
Wockhardt Files European Marketing Application for Novel Antibiotic WCK 5222
Wockhardt, a company that makes medicines, has asked the European Medicines Agency (EMA) for permission to sell a new antibiotic called WCK 5222.
This drug is special because it can help fight infections that are hard to treat with other medicines.
The EMA is checking the drug's information quickly because it's really needed.
Wockhardt also asked the US and Indian governments to approve this drug.
They did tests with the drug on people who were very sick, and it helped more than 50 people.
This is the first time a drug made in India has been asked to be sold all over Europe.
Wockhardt filed a Marketing Authorisation Application (MAA) with the EMA for its novel antibiotic WCK 5222.
WCK 5222 is a combination of Zidebactam (1 g) and Cefepime (2 g) for treating resistant Gram-negative infections.
The EMA granted WCK 5222 an Accelerated Assessment, allowing for a faster review process due to its unmet medical need.
The drug has completed a global Phase III clinical trial and is under fast-track review by the USFDA.
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation.
- Who
- Wockhardt, a drugmaker
- What
- Filed a Marketing Authorisation Application (MAA) for WCK 5222 in Europe
- Where
- European Medicines Agency (EMA), covering 30 countries in the EU and EEA
- When
- January 7, 2026
- Why
- To address the unmet medical need for treating resistant Gram-negative infections
Key facts
- Company
- Wockhardt
- Drug Name
- WCK 5222 (Zaynich)
- Components
- Zidebactam (1 g) and Cefepime (2 g)
- Regulatory Bodies
- European Medicines Agency (EMA), USFDA, Indian regulatory authorities
- Indication
- Resistant Gram-negative infections
- Clinical Trial Phase
- Phase III
- Compassionate Use Patients
- More than 50 in India and the US
Quotes
Wockhardt
A pharmaceutical company that developed the antibiotic WCK 5222.
“Prior to this, multiple Phase I clinical pharmacology studies involving the Zidebactam/Cefepime combination were successfully conducted in the United States. Zaynich has also completed a multi-indication clinical study in India, specifically targeting carbapenem-resistant infections. To date, more than 50 patients in India and the US suffering from highly resistant infections have been treated with Zaynich under compassionate use programs.”
thehindubusinessline.com
“This pathway allows for an abridged review timeline, reflecting the unmet medical need addressed by the product. The New Drug Application (NDA) on WCK 5222 is already under fast-track review by the USFDA.”
thehindubusinessline.com
Sources
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