Eisai recently communicated their decision to discontinue human trials and manufacturing of the experimental therapy, lorcaserin. The current Phase 3 trial has been discontinued and the Extended Access Program will end in November 2024. Patients will need to discontinue lorcaserin by October to complete final study visits no later than November. Unfortunately, there will no longer be the ability to access lorcaserin after this time.
This was brought to the attention of DSF when families participating in these studies were first informed by their study sites, and we have since had discussions with Eisai to better understand the scope of the situation and investigate any alternatives. DSF understands the incredibly difficult situation this poses for the patients and families that have had success with lorcaserin and are now facing the reality of weaning an effective anti-seizure medication in a patient that has failed many other anti-seizure medications.
If your loved one is impacted by this announcement, please connect with DSF.
There may be some alternative options to consider as you navigate weaning lorcaserin.
Send an email to veronica@dravetfoundation.org.
What is the history of lorcaserin (Belviq) in the treatment of Dravet syndrome?
Lorcaserin was previously marketed as Belviq by Eisai as an FDA-approved weight-loss drug. Some research in animal models and small studies in humans provided data suggesting that lorcaserin, as well as other similar drugs that target serotonin signaling, might be effective for the treatment of seizures in Dravet syndrome. At this time, some patients began to use Belvig (lorcaserin) “off-label.” The term off-label refers to using a therapeutic in a manner that is not specified in the FDA’s approved package labeling; this can be either for treatment of symptoms that are not part of that label or for a disease other than what it is approved to treat.
In February of 2020, Eisai voluntarily withdrew Belviq from the market at the request of federal regulators. An analysis by the FDA had shown that 7.7% of participants who took Belviq were diagnosed with cancer, slightly more than the 7.1% who developed cancer in a control group not receiving Belviq. However, Eisai was not aware of the patients with Dravet syndrome that were using Belviq successfully off-label. DSF reached out to Eisai on behalf of the community, and Eisai spoke with the FDA about continuing to supply Belviq to patients with Dravet syndrome via an Extended Access Program. Subsequently, Eisai began a Phase 3, placebo-controlled study to formally evaluate the efficacy of lorcaserin (previously Belviq) in patients with Dravet syndrome. Upon completion of the Phase 3 study, participants then had the option to transition to the Extended Access Program and continue to receive lorcaserin.
Why are the studies for lorcaserin ending?
Eisai has indicated that the recruitment for these studies was difficult, meaning they could not gather the amount of data they would need to show whether lorcaserin is an effective treatment option for Dravet syndrome. Lorcaserin is thought to work by targeting the serotonin pathway, which means being on another serotonin-modulating medication is contraindicated and would prevent participation in the studies for lorcaserin. At the time the studies for lorcaserin began enrolling, Fintepla (fenfluramine) had just received FDA approval. Fintepla also targets the serotonin pathway. Just as the studies for lorcaserin began, many patients were trying the newly available Fintepla for the first time, which may have been a factor in the difficulties enrolling enough participants in the study.
What are the options for patients who will no longer have access to lorcaserin?
- Please connect with DSF directly if your loved one is impacted by this situation. There may be additional options to consider. Email: veronica@dravetfoundation.org
- In 2022, there was an expert consensus on the top-line treatments for Dravet syndrome. You can find more information here.
- There are several clinical trials currently enrolling or upcoming for Dravet syndrome. You can find more information at dravetclinicaltrials.org.
