BOTOX alternative to face delays? Evolus' CMO hit with Form 483

By Flora Southey contact

- Last updated on GMT

GettyImages/bandit2523
GettyImages/bandit2523

Related tags: Food and drug administration, Fda

Ten manufacturing violations at a South Korean CMO facility could delay US FDA approval of a BOTOX alternative, says Evolus.

Evolus' candidate PrabotulinumtoxinA (DWP-450) is an injectable 900 kilodalton, or kDa, botulinum toxin type A complex being developed as an alternative to Allergan's onabotulinumtoxinA (BOTOX).

But the US Food and Drug Administration (FDA) has issued Evolus’ contract manufacturing organisation (CMO) Daewoong Pharmaceuticals with a Form 483​, following a pre-approval inspection at its Gyeonggi-do facility in November, 2017.  

Current good manufacturing practice (cGMP) violations cited relate to environmental monitoring, drug substance testing, computer system access, staff training and material handling.

According to the FDA, black particles found during the visual inspection of process validation failed to trigger an investigation “to determine the source of particles and the recurrence of this issue.”

Temperature distribution tests for the firm’s anaerobic chamber did not meet performance qualification criteria, said the Administration, which attributed the failure “to the aging of the equipment.”

Further, the Administration said Daewoong consistently failed to use the SAP (Systems, Applications and Products for data processing) system for material inventory and location.

An elevated risk of drug substance contamination was also noted by the FDA.

Delay concerns

Daewoong has responded to the FDA, however in a US Securities and Exchange Commission (SEC) filing​ issued January 9 Evolus raised concerns the Form 483 could delay drug approval.

“The FDA may not be satisfied with the response, and it may require Daewoong to take additional corrective actions or other measures, require re-inspection, or decline to approve the facility, which could result in approval delays,” ​said Evolus.

The US Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) date of May 15, 2018 for completing review of its Biologics License Application (BLA). 

According to the filing, the European Medicines Agency (EMA) is expected to inspect Daewoong’s site in the first quarter of 2018.

Correction: DWP-450 is not being developed as a biosimilar to BOTOX as the original article said.

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