In addition to raw drug substances, finished drug manufacturing facilities are also classified as VAI.
Preparing to resubmit NDA for rivoceranib/camrelizumab combination therapy
HLB (028300)'s new liver cancer drug, Rivoceranib, has further reduced the burden on manufacturing facilities ahead of its re-approval by the U.S. Food and Drug Administration (FDA). Previously, the FDA inspection of the finished drug manufacturing facility, following the raw drug product manufacturing facility, was completed with a ‘Voluntary Corrective Action Recommendation (VAI).’
HLB announced on the 6th that the FDA has finally classified the routine pharmaceutical manufacturing and quality management (cGMP) inspection of the Rivoceranib finished drug manufacturing facility as VAI.
HLB's U.S. subsidiary Elevar Therapeutics received a due diligence completion letter from its partner, China's Hengseo Pharmaceutical, on the 3rd.
VAI is a classification given when an issue has been confirmed in an FDA inspection, but official regulatory action is not recommended because it is judged to be at a level where the company can make voluntary corrections. The FDA's inspection results are divided into NAI with no findings, VAI requiring voluntary corrective action, and OAI requiring formal regulatory action.
In addition to raw materials, VAI also provides finished products… Manufacturing facility inspection completed
As a result of this result, the uncertainty related to manufacturing facilities that had continued since receiving the supplementation request letter (CRL) in July was greatly reduced.
Eleva is seeking FDA approval for the combination therapy of riboceranib and Hengseo Pharmaceutical's immunotherapy drug camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.
The FDA sent a CRL for the new drug application (NDA) for riboceranib last July. At the time, cGMP issues at the Hengseo Pharmaceutical manufacturing facility listed in the NDA, rather than clinical efficacy or safety, became an obstacle to approval review.
Afterwards, the FDA inspection of the Rivoceranib raw drug manufacturing facility was completed by VAI. However, as the finished drug manufacturing facility received Form 483 in a separate inspection, all procedures related to the manufacturing facility were not completed.
Form 483 is a document delivered to the company when an FDA inspector identifies items that may not comply with relevant regulations during the inspection process. Hangseo Pharmaceutical has been taking corrective action in response to the pointed out issues.
This time, finished drug manufacturing facilities have been classified as VAI, and both raw material and finished product manufacturing facilities have completed FDA inspection procedures.
HLB reduces the burden on manufacturing facilities… Preparing to resubmit NDA for new liver cancer drug
Eleva and Hengseo Pharmaceutical are currently preparing the final data needed to resubmit the NDA for a new liver cancer drug. The company plans to resubmit the application to the FDA as soon as related work is completed.
This VAI classification is meaningful in that it lowers the burden related to manufacturing facilities ahead of NDA resubmission. However, VAI is a classification for inspection of manufacturing facilities and does not mean whether a new drug has been approved. After resubmission of the NDA, the FDA's submission and review process goes through again.
An HLB official said, “This VAI classification is the result of Hangseo Pharmaceutical’s proactive response by concentrating its company-wide capabilities to resolve inspection issues,” and added, “Eleva will work closely with Hengseo Pharmaceutical to quickly complete preparations for resubmission of the NDA for a liver cancer new drug and respond without disruption to the subsequent FDA review.”
