Daratumumab and hyaluronidase-fihj - Biologic Drug Details

Summary for daratumumab and hyaluronidase-fihj

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for daratumumab and hyaluronidase-fihj

Mechanism of Action	CD38-directed Antibody Interactions
Established Pharmacologic Class	CD38-directed Cytolytic Antibody Endoglycosidase
Chemical Structure	Antibodies, Monoclonal Glycoside Hydrolases

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for daratumumab and hyaluronidase-fihj Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for daratumumab and hyaluronidase-fihj Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2040-10-06	Company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145			Company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2025-03-23	Company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2027-09-26	Company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2030-09-21	Company disclosures

3) Low Certainty: US Patents for daratumumab and hyaluronidase-fihj Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

Market Dynamics and Financial Trajectory for Daratumumab and Hyaluronidase-fihj (DARZALEX FASPRO)

Introduction

Daratumumab and hyaluronidase-fihj, marketed as DARZALEX FASPRO, is a groundbreaking subcutaneous formulation of daratumumab, a CD38-directed antibody, co-formulated with recombinant human hyaluronidase PH20 (rHuPH20). This drug has revolutionized the treatment of multiple myeloma and other related conditions, significantly impacting the market dynamics and financial trajectory of its developers and the broader pharmaceutical industry.

Approval and Indications

DARZALEX FASPRO received its first U.S. FDA approval in May 2020 for the treatment of adult patients with newly diagnosed or relapsed/refractory multiple myeloma[3].

• It is approved for several indications, including combination therapies with bortezomib, lenalidomide, and dexamethasone, and as a monotherapy for relapsed or refractory multiple myeloma[4].

Clinical Efficacy and Market Impact

The clinical efficacy of DARZALEX FASPRO has been demonstrated through several Phase 3 trials, including the PERSEUS and AQUILA studies.

• PERSEUS Study: This study showed significant clinical improvement with a DARZALEX FASPRO-based quadruplet induction, consolidation, and maintenance regimen in transplant-eligible newly diagnosed multiple myeloma patients. The data highlighted an unprecedented progression-free survival (PFS) rate and higher overall response rates compared to standard therapies[2][5].

• AQUILA Study: This study demonstrated that DARZALEX FASPRO significantly delayed progression from high-risk smoldering multiple myeloma to active multiple myeloma and extended overall survival compared to active monitoring. The study showed a 51% reduction in the risk of progression to active multiple myeloma[4].

Market Penetration and Adoption

The approval and positive clinical data have led to rapid market penetration and adoption of DARZALEX FASPRO.

• Prescribing Trends: The drug's subcutaneous administration, which is more convenient than intravenous infusion, has been a key factor in its adoption. This convenience, combined with its efficacy, has made it a preferred choice for clinicians treating multiple myeloma[3].

• Patient Outcomes: The significant improvement in patient outcomes, including higher response rates and extended PFS, has further solidified its position in the market. This has led to increased prescriptions and a growing market share in the multiple myeloma treatment segment[2][4].

Financial Trajectory

The financial trajectory of DARZALEX FASPRO is robust and promising.

• Revenue Growth: Since its approval, DARZALEX FASPRO has contributed significantly to the revenue of its developers, Janssen Biotech, Inc., and Genmab A/S. The drug's multiple indications and strong clinical data have driven revenue growth, making it one of the key products in their portfolios[1][4].

• Milestone Payments: Genmab has received milestone payments, such as a $30 million payment upon the first commercial sale of DARZALEX FASPRO for the treatment of newly diagnosed light-chain (AL) amyloidosis[1].

• Market Projections: With ongoing clinical trials and potential new indications, the market projections for DARZALEX FASPRO are optimistic. Analysts predict continued revenue growth as the drug becomes a standard of care in multiple myeloma treatment.

Competitive Landscape

DARZALEX FASPRO operates in a competitive landscape but has several unique advantages.

• First and Only Subcutaneous CD38-Directed Antibody: It is the only subcutaneous CD38-directed antibody approved for multiple myeloma, offering a distinct advantage over intravenous formulations[3].

• Comprehensive Clinical Data: The extensive clinical data from Phase 3 trials have established DARZALEX FASPRO as a leader in its class, making it a preferred option for clinicians and patients alike[2][4].

Regulatory Environment

The regulatory environment has been supportive of DARZALEX FASPRO.

• FDA Approvals and Reviews: The FDA has approved DARZALEX FASPRO under various programs, including the Real-Time Oncology Review (RTOR) pilot program, which expedited the review process. This has facilitated quicker market access and broader patient reach[1][3].

• Supplemental New Drug Applications (sNDAs): Ongoing sNDAs, such as the one supported by the PERSEUS trial, continue to expand the drug's indications, further solidifying its market position[5].

Patient Access and Affordability

Efforts to improve patient access and affordability are crucial for the long-term success of DARZALEX FASPRO.

• Reimbursement and Pricing: The developers have been working with healthcare systems to ensure reimbursement and affordable pricing, which is essential for widespread adoption and patient access[4].

• Patient Assistance Programs: Various patient assistance programs have been implemented to help patients cover the costs associated with the treatment, enhancing accessibility[4].

Future Outlook

The future outlook for DARZALEX FASPRO is promising, with several factors contributing to its continued success.

• Ongoing Clinical Trials: Ongoing and planned clinical trials are expected to expand the drug's indications and reinforce its position in the market. For example, the AQUILA study's findings on preventing progression from high-risk smoldering multiple myeloma to active multiple myeloma open new avenues for treatment[4].

• Technological Advancements: The use of Halozyme’s ENHANZE drug delivery technology, which enables subcutaneous administration, continues to be a technological advantage. Further advancements in drug delivery could enhance patient convenience and compliance[2].

Key Takeaways

• Clinical Efficacy: DARZALEX FASPRO has demonstrated significant clinical efficacy in multiple myeloma and related conditions.
• Market Penetration: The drug has achieved rapid market penetration due to its convenience and strong clinical data.
• Financial Growth: It has contributed substantially to the revenue of its developers and is projected to continue growing.
• Regulatory Support: The FDA has been supportive through various approval programs.
• Patient Access: Efforts to improve patient access and affordability are ongoing.

FAQs

Q: What is DARZALEX FASPRO, and how is it administered? A: DARZALEX FASPRO is a subcutaneous formulation of daratumumab and hyaluronidase-fihj, administered via injection into the abdomen over approximately 3 to 5 minutes[3].

Q: What are the approved indications for DARZALEX FASPRO? A: It is approved for various indications in multiple myeloma, including combination therapies for newly diagnosed and relapsed/refractory patients, and for the treatment of newly diagnosed light-chain (AL) amyloidosis[1][4].

Q: What are the key findings from the PERSEUS and AQUILA studies? A: The PERSEUS study showed significant improvement in PFS and overall response rates in transplant-eligible newly diagnosed multiple myeloma patients. The AQUILA study demonstrated a 51% reduction in the risk of progression from high-risk smoldering multiple myeloma to active multiple myeloma[2][4].

Q: How has DARZALEX FASPRO impacted the market for multiple myeloma treatments? A: It has become a preferred treatment option due to its convenience, efficacy, and strong clinical data, leading to rapid market penetration and significant revenue growth for its developers[1][3].

Q: What are the future prospects for DARZALEX FASPRO? A: With ongoing clinical trials and potential new indications, DARZALEX FASPRO is expected to continue growing in the market, further solidifying its position as a leading treatment for multiple myeloma and related conditions[4].

Cited Sources

1. Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO®
2. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
3. FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma
4. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) shows 51 percent reduction in risk of progression to active multiple myeloma
5. FDA Receives sNDA for Daratumumab Combo in Newly Diagnosed Multiple Myeloma

Last updated: 2024-12-16