Despite Market Access Hurdles and Limited Familiarity Hampering Initial Uptake, Neurologists Project Robust Future Use of Relyvrio for the Treatment of ALS, According to Spherix Global Insights

Recent research suggests Relyvrio will benefit from the limited number of therapies approved to slow decline in ALS

EXTON, Pa., March 9, 2023 /PRNewswire/ -- With the FDA approval of Amylyx's Relyvrio (AMX0035; sodium phenylbutyrate and taurursodiol) for amyotrophic lateral sclerosis (ALS) in September 2022, patients gained access to only the third novel molecule approved for this rare, neurodegenerative disease. Mitsubishi Tanabe's edaravone formulations (IV Radicava and oral Radicava ORS) and different riluzole formulations (generics, ITF Pharma's thickened oral suspension Tiglutik, and Mitsubishi Tanabe's oral film Exservan) are the only other approved disease-modifying therapies approved for ALS.

At this early stage of launch, the majority of neurologists/neuromuscular specialists (n=68) surveyed in February 2023 reported actively discussing Relyvrio with their ALS patients, typically at their next scheduled visit with relevant candidates. Respondents consider ALS patients with early-stage disease to be the most appropriate candidates for Relyvrio, suggesting that HCPs already perceive it as a first-line therapy.

However, even with these generally positive opinions on Relyvrio, reimbursement hassles and out-of-pocket costs are currently key barriers to use. Specifically, data reveal that two in five ALS patients deemed clinically appropriate for Amylyx's brand are not able to receive it due to coverage or co-pay issues. As mentioned by one neurologist unaided when queried on the biggest disadvantage of Relyvrio, "Access is absolutely ridiculous. I spent so much of my time going back-and-forth and it takes forever to get the medication."

Delays in access to medications are felt especially acutely in this market and are underscored as a particularly greater barrier given the often-rapid progression of the disease and need for fast treatment.

With half of neurologists never having been visited by an Amylyx sales representative, lack of familiarity is also a primary obstacle to increased Relyvrio use. Notably, only a minority of respondents consider Amylyx to be executing well on Relyvrio's launch and few feel that the manufacturer has given them the necessary information to confidently initiate patients on the brand. When asked for advice to Amylyx on Relyvrio's launch, an interviewed respondent highlighted the need for additional outreach: "The biggest thing I would recommend to them is they are not doing as great of a job getting the word out. I don't know if it's because they're still hesitant and waiting for the rest of the data to come out."

Despite these obstacles, the majority of neurologists anticipate initiating trial of Relyvrio in their ALS patients over the next six months, likely in combination with other therapies, such as riluzole, in order to provide maximum therapeutic benefit for patients.

Even with the noted advance that Relyvrio brings to the market, neurologists are also keen to point out that there is still a large unmet need for new and advanced treatment options. Given the large pipeline of diverse emerging therapies in ALS, including Biogen's tofersen, Apellis Pharmaceuticals' pegcetacoplan, GSK/Alector's latozinemab (GSK4527223/AL-001), Novartis' BLZ945, Sanofi's SAR443820, Ionis Pharmaceuticals' ION363, and Cytokinetics' reldesemtiv, there is hope for new options to bring relief to this underserved patient population.

Spherix will continue to track the launch performance of Relyvrio in the ALS market via the Launch Dynamix™: Relyvrio (Amylyx) in ALS report series and will begin tracking the launch of tofersen in ALS if approved on its April 25^th, 2023 PDUFA date.  

About Launch Dynamix™

Launch Dynamix: Relyvrio (Amylyx) in ALS is an independent service providing quarterly deep dives into launch benchmarks, promotional activity, barriers to uptake, and patient types gravitating to the new brand.

About Spherix Global Insights

Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company's unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.

A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.

To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter.

Spherix Global Insights Contacts
Emma McFadden, Senior Insights Director, Neurology
[email protected]

Scott Upham, Corporate Communications
[email protected]

NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement by any company, brand, or product aforementioned.

SOURCE Spherix Global Insights