Halozyme Announces Janssen Submission For FDA Approval Of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) For The Treatment Of Patients With Light Chain (AL) Amyloidosis
Halozyme Therapeutics announced that Janssen Biotech submitted a supplemental Biologics License Application (sBLA) to the FDA for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) to treat light chain (AL) amyloidosis, a serious disease with no approved therapies. The application is backed by positive results from the Phase 3 ANDROMEDA study, which achieved its primary endpoint. This sBLA is evaluated under the FDA's Real-Time Oncology Review program, aiming for expedited patient access to treatments. The approval process does not guarantee success.
- sBLA submission for DARZALEX FASPRO for AL amyloidosis treatment represents a new market opportunity.
- Positive results from the ANDROMEDA study support the potential approval.
- The Real-Time Oncology Review program could expedite the approval process.
- The sBLA approval is not guaranteed despite the supportive study results.
SAN DIEGO, Sept. 10, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab utilizing Halozyme's ENHANZE® technology, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies1,2. The sBLA is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June 2020. Janssen's ANDROMEDA study evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate.
"We are excited that DARZALEX FASPROTM utilizing our ENHANZE® technology has the potential to be approved in a new indication," said Dr. Helen Torley, president and chief executive officer. "Patients diagnosed with AL amyloidosis currently have no approved therapeutic options and we are therefore pleased that a new treatment for the disease may soon be available."
The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. The RTOR program aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR program does not guarantee or influence approvability of the supplemental application.
The submission is also being reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies.3
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, the product development and approval efforts of Halozyme's ENHANZE® partners and statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the FDA Real-Time Oncology Review program and the potential for a more efficient regulatory review process of the sBLA referenced in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 National Organization for Rare Disorders. Amyloidosis. Accessed August 20, 2020. https://rarediseases.org/rare-diseases/amyloidosis/.
2 Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928.
3 Project Orbis. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Accessed July 2020.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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