BLA Resubmission to be Formally Filed Today
Commercial Launch Planned for Spring 2019
IRVINE, CA, USA I August 02, 2018 I Evolus, Inc. (NASDAQ:EOLS), a company dedicated to aesthetic medicine, announced that today it is resubmitting its Biologics License Application (“BLA”) for its lead product candidate, DWP-450 (prabotulinumtoxinA), to the U.S Food and Drug Administration (“FDA”).
The resubmission follows the receipt of a Complete Response Letter (“CRL”) from the FDA in May 2018 which necessitated the submission of additional data to the FDA for the completion of review of Evolus’ BLA. Deficiencies cited by the FDA in the CRL were isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. No deficiencies were related to clinical, non-clinical or safety matters.
David Moatazedi, President and Chief Executive Officer of Evolus, commented, “Today we are resubmitting our BLA well ahead of our guided timeline and less than 90 days since receiving our CRL. We believe this submission gives us a line of sight to the anticipated approval and subsequent commercialization of DWP-450.”
Mr. Moatazedi continued, “We look forward to receiving notice next month of the FDA’s acceptance of our resubmission and the assignment of a new FDA action date. We are working towards the planned commercial launch of DWP-450 in spring 2019 as we further accelerate the build out of our sales and marketing team and finalize our go-to-market strategy.”
About Evolus, Inc.
Evolus is a company dedicated to aesthetic medicine focused on providing physicians and their patients with expanded choices in aesthetic treatments and procedures. Evolus’ lead candidate DWP-450, also known by the chemical name prabotulinumtoxinA, is a 900 kDa purified botulinum toxin type A complex that is being evaluated for the treatment of moderate to severe glabellar lines in adult patients.
SOURCE: Evolus
Post Views: 36
BLA Resubmission to be Formally Filed Today
Commercial Launch Planned for Spring 2019
IRVINE, CA, USA I August 02, 2018 I Evolus, Inc. (NASDAQ:EOLS), a company dedicated to aesthetic medicine, announced that today it is resubmitting its Biologics License Application (“BLA”) for its lead product candidate, DWP-450 (prabotulinumtoxinA), to the U.S Food and Drug Administration (“FDA”).
The resubmission follows the receipt of a Complete Response Letter (“CRL”) from the FDA in May 2018 which necessitated the submission of additional data to the FDA for the completion of review of Evolus’ BLA. Deficiencies cited by the FDA in the CRL were isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. No deficiencies were related to clinical, non-clinical or safety matters.
David Moatazedi, President and Chief Executive Officer of Evolus, commented, “Today we are resubmitting our BLA well ahead of our guided timeline and less than 90 days since receiving our CRL. We believe this submission gives us a line of sight to the anticipated approval and subsequent commercialization of DWP-450.”
Mr. Moatazedi continued, “We look forward to receiving notice next month of the FDA’s acceptance of our resubmission and the assignment of a new FDA action date. We are working towards the planned commercial launch of DWP-450 in spring 2019 as we further accelerate the build out of our sales and marketing team and finalize our go-to-market strategy.”
About Evolus, Inc.
Evolus is a company dedicated to aesthetic medicine focused on providing physicians and their patients with expanded choices in aesthetic treatments and procedures. Evolus’ lead candidate DWP-450, also known by the chemical name prabotulinumtoxinA, is a 900 kDa purified botulinum toxin type A complex that is being evaluated for the treatment of moderate to severe glabellar lines in adult patients.
SOURCE: Evolus
Post Views: 36
