FDA Declines Approval for J&J’s Subcutaneous Rybrevant and AstraZeneca’s Full Approval Bid for Andexxa

J&J's Subcutaneous Rybrevant Rejection:
The FDA issued a Complete Response Letter (CRL) for Johnson & Johnson's Biologics License Application (BLA) for a subcutaneous formulation of amivantamab (Rybrevant) in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The CRL is related to manufacturing facility issues and not to the product's efficacy or safety data4.

AstraZeneca's Andexxa Full Approval Bid Denied:
AstraZeneca's bid for full FDA approval of its anticoagulant reversal drug Andexxa was denied following a critical advisory committee meeting. The FDA expressed skepticism over the accompanying data, leading to the denial25.

Impact on Current Treatments:
The currently approved intravenous (IV) formulation of Rybrevant is not impacted by the CRL, and J&J is working closely with the FDA to resolve the issues and bring the subcutaneous formulation to patients as quickly as possible4.

Regulatory Context:
These decisions reflect the FDA's rigorous evaluation process for new drug applications, emphasizing the importance of comprehensive data and manufacturing compliance.

Sources:

2. https://endpts.com/astrazeneca-denied-full-fda-approval-of-andexxa-after-adcomm/

4. https://www.jnj.com/media-center/press-releases/update-on-u-s-regulatory-review-of-subcutaneous-amivantamab

5. https://endpts.com/fda-raises-safety-questions-on-astrazenecas-bleeding-reversal-agent/