Soleo Health to Administer OXLUMO™ for the Treatment of Primary Hyperoxaluria Type 1

Rhea-AI Summary

Soleo Health has announced FDA-approved access to OXLUMO™ (lumasiran) for treating primary hyperoxaluria type 1 (PH1) in patients as young as three months. This marks a significant advancement in specialty pharmacy services for an ultra-rare genetic disorder characterized by excessive oxalate production, leading to kidney issues. Soleo Health will administer OXLUMO injections in its Ambulatory Infusion Centers, supported by trained clinical teams. The initiative aligns with Soleo's commitment to innovative pharmacy services and patient-centered care.

Positive

• FDA approval for OXLUMO provides a new treatment option for PH1, addressing a critical patient need.
• Soleo Health's nationwide Ambulatory Infusion Centers enhance drug accessibility and patient care.

Negative

• None.

Company to Administer First FDA-Approved PH1 Drug to Lower Urinary Oxalate Levels

FRISCO, Texas--(BUSINESS WIRE)-- Soleo Health, an innovative leader and national provider of complex specialty pharmacy services, announced today it has access to OXLUMO™ (lumasiran), managed by Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company. This access allows Soleo Health to administer OXLUMO to lower patients' urinary oxalate levels in children and adults with primary hyperoxaluria type 1 (PH1), an ultra-rare genetic disorder.

OXLUMO is the first and only U.S. Food and Drug Administration-approved prescription medication for treating PH1 in infants as young as three months of age, children, and adults. PH1 causes the liver to produce an excessive amount of the compound, oxalate. A liver enzyme preventing the accumulation of oxalate is not produced in sufficient quantities to break down oxalate, thus resulting in recurring kidney and urinary stones, which over time, can result in chronic kidney disease and eventually lead to kidney failure. OXLUMO reduces oxalate production, thereby preventing stone formation.

Soleo Health offers OXLUMO injections across its Ambulatory Infusion Centers (AICs) nationwide, supported and administered by its dedicated staff, who are trained on the clinical profile and delivery of services for OXLUMO. The staff includes specially trained interdisciplinary teams, comprising highly experienced therapy-care pharmacists, registered nurses and reimbursement and patient care ambassadors. Soleo Health’s extensive expertise in administering specialty pharmaceuticals – particularly in treating rare or ultra-rare diseases – makes the Company an important resource to bring OXLUMO to patients.

Additionally, Soleo Health’s proprietary clinical outcomes program, SoleMetrics®, which collects and produces valuable real-world data over time, will gather intelligent outcomes from patients receiving OXLUMO throughout their journeys.

“Soleo Health continues to be on the leading edge of bringing patients the latest innovative options in complex specialty pharmacy services. We can now administer OXLUMO, which helps complement the numerous other rare and ultra-rare drug distribution products we deliver with the customized, high-quality clinical care we provide,” explained Drew Walk, Soleo Health chief executive officer.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for treating a wide range of severe and debilitating diseases. Founded in 2002, Alnylam delivers a bold vision to turn scientific possibility into reality with a robust RNAi therapeutics platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), GIVLAARI® (givosiran), and OXLUMO™ (lumasiran), as well as Leqvio® (inclisiran), which is being developed and commercialized by Alnylam’s partner Novartis. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter @Alnylam or LinkedIn.

About Soleo Health

Frisco, Texas-based Soleo Health is an innovative national provider of complex specialty pharmacy services administered in the home or alternate sites of care. Soleo Health’s interdisciplinary team, comprised of experienced clinical pharmacists and registered nurses, utilizes a consistent patient management process, which leads to quantifiable clinical and economic value while improving the patient experience.

Soleo Health operates 21 locations throughout the U.S. with national nursing coverage and pharmacy licensure in 50 states and is accredited by URAC and The Joint Commission.

For more information, visit www.soleohealth.com or connect with Soleo Health on LinkedIn, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220111005255/en/

Susan Turkell, 303-766-4343, sturkell@pairelations.com

Source: Soleo Health

FAQ

What is OXLUMO and how does it relate to Alnylam Pharmaceuticals (ALNY)?

OXLUMO™ (lumasiran) is the first FDA-approved drug for treating primary hyperoxaluria type 1 (PH1), developed by Alnylam Pharmaceuticals (ticker: ALNY).

How does Soleo Health administer OXLUMO to patients?

Soleo Health administers OXLUMO via injections in its Ambulatory Infusion Centers, supported by trained healthcare professionals.

What are the benefits of OXLUMO for patients with PH1?

OXLUMO reduces oxalate production, preventing kidney stones and chronic kidney disease in patients with primary hyperoxaluria type 1.

When was OXLUMO approved by the FDA?

OXLUMO was granted FDA approval as the first treatment option for PH1, marking a significant milestone in managing this rare genetic disorder.