International Alliance

Supports a claim in this answer

a slowing of functional decline of about 2.49 points on the ALSFRS-R over 24 weeks in a specific group of early-stage patients

✓Supports this

“It is not known how comparable the edaravone tested in ADORE is to the approved product, and no detailed comparison has been published.”

States the comparability gap directly, in the same paragraph that describes the ADORE result. This is why the ADORE finding cannot be read across to the approved oral edaravone.

It is unknown how comparable this form of edaravone is to the MT Pharma drug and no detailed comparison has been published to date beyond a brief statement in this publication.

Edaravone IV in Clinical Trials

✓Supports this

“The ADORE trial tested TW001, an oral edaravone made by a different company from the approved product, and it did not do better than placebo.”

Names the drug ADORE tested and who made it: TW001, also called FAB122, developed by Treeway in the Netherlands. This is not the approved oral edaravone, Radicava ORS, which comes from a different manufacturer and is covered separately on the same page.

TW001, also called FAB122, was tested in a double-blind, placebo-controlled Phase 3 clinical trial across Europe, called the ADORE study, that did not demonstrate benefit versus placebo.

Edaravone IV in Clinical Trials

✓Supports this

“The trial that showed a benefit for edaravone enrolled only people who met early-stage criteria, and found a 2.49 point difference on the ALSFRS-R over 24 weeks.”

Gives the same figure, 2.49 ALSFRS-R points over 24 weeks, and the context behind it. The first trial found no significant benefit. Looking back at its results suggested people earlier in the disease had done better, and the second trial was then built around only those people, which is where the figure comes from.

Follow up (post-hoc) analysis revealed that a subgroup of participants earlier in the disease appeared to benefit compared to those further progressed.

Edaravone IV in Clinical Trials

!Qualifies this

“Edaravone's benefit looks strongest in people who start early and fit specific criteria, and it is not regarded as equally effective for everyone.”

The Alliance's current assessment is more uncertain than the answer. It says the picture is still changing and that studies disagree, with some finding no benefit at all rather than a smaller one. A separate European trial, ADORE, tested a different oral edaravone made by another company and did not show a benefit over placebo.

There are conflicting results with some studies suggesting a small benefit while other studies show no benefit.

Current Status

✓Supports this

“Studies of edaravone disagree. Some find a small benefit and some find none.”

The Alliance's current assessment says the picture is still changing and that studies disagree, with some finding no benefit at all rather than a smaller one.

There are conflicting results with some studies suggesting a small benefit while other studies show no benefit.

Current Status

Further reading

Overview of how edaravone is used in ALS and the evidence behind it