1. Scrip
  2. >>New Products

US CRL For Astellas's Zolbetuximab Over Manufacturing Issues

Revised Approval Timeline Unclear

 
• By Lisa Takagi

Astellas has received a US CRL for it's potential first-in-class drug zolbetuximab, after questions over a manufacturing line came up after an FDA site inspection and could not be answered by the original 12 January PDUFA date. The Japanese firm will refile the application after resolving the issues, but the likely revised timeline is not yet clear.

Supposed-to-be the global first approval for zolbetuximab was stopped due to manufacturing issues.
potential global-first approval of zolbetuximab hits road bump • Source: Shutterstock

Astellas Pharma, Inc. has received a Complete Response Letter (CRL) from the US Food And Drug Administration for its potential first-in-class Claudin 18.2 inhibitor zolbetuximab, due to “the unresolved deficiencies following its [FDA] pre-license inspection of a third-party manufacturing facility” which could not be answered by the original Prescription Drug User Fee Act (PDUFA) action date of 12 January.

The Japanese firm stressed the US regulator had raised no concerns over the safety or efficacy of the drug as...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Ten Approvals And Fourteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Biogen Edges Closer To Growth On Strong Q2

 
• By Jessica Merrill

Sales of Leqembi, Zurzuvae and Skyclarys contributed to Biogen’s sales and earnings guidance raise, positioning the company closer to potential growth.

PTC To Challenge BioMarin In PKU With Oral Sephience

 
• By Joseph Haas

PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.

Apellis’ Empaveli Expansion Underway In Rare Kidney Disease

 
• By Jessica Merrill

The US FDA approved the complement C3 inhibitor for new indications in C3G and primary IC-MPGN, providing a new growth opportunity for Apellis.

More from Scrip

Cardiff Pushes Towards Colorectal Cancer Phase III As Funding Questions Loom

 
• By Manas Mishra

Cardiff Oncology is open to going it alone, a partnership and even an exit as the San Diego, CA-based firm tries to push its PLK1 inhibitor through late-stage development.

Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

 
• By Anju Ghangurde

Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.

Allogene Sticks With Standard Lymphodepletion In CAR-T Trial After Patient Death

 
• By Alaric DeArment

The company said it will no longer use ALLO-647 after a patient developed a fatal adenovirus infection, and it will pursue further development of its Dagger technology to minimize or eliminate the need for lymphodepletion.