Teva-Handok challenges mkt with LAI risperidon, Uzedy

Subcutaneous injectable with 1-month and 2-month dosing options, immediate effect without a loading dose

Improved the risk of relapse by 80%…expected to decrease injectable pain and increase patient adherence

Reimbursement is essential to compete with existing treatments…"We will pursue reimbursement following the standard procedue after receiving approval"

As the schizophrenia treatment paradigm shifts toward managing medication adherence, Teva-Handok has introduced Uzedy (risperidone), a long-acting subcutaneous containing risperidone, to the Korean market.

 

Uzedy is expected to become a new treatment option, enhancing patient convenience with its 1-month and 2-month dosing options and a design that eliminates the need for a loading dose.

 

This drug has been shown to reduce the risk of relapse by up to 80% compared to placebo.

 

Uzedy logo

Teva-Handok recently announced that its long-acting subcutaneous injectable for adult schizophrenia, Uzedy (risperidone), received approval from the Ministry of Food and Drug Safety (MFDS) on September 5.

 

It is assessed as a new treatment option that overcomes the medication adherence issues associated with existing oral therapies and provides convenience for both patients and medical professionals.

 

Notably, it is expected to contribute to securing 'treatment persistence,' which is critical in schizophrenia management.

 

Uzedy is an long-acting injectable that can be administered at 1-month and 2-month intervals, developed specifically to address poor medication adherence, cited as the primary cause of schizophrenia relapse.

 

Schizophrenia is a chronic, progressive mental illness affecting thought, emotion, and behavior, with about 80% of patients experiencing multiple relapses within the first five years of treatment initiation.

 

Since repeated relapses can diminish treatment effectiveness, impair daily functioning, and even cause structural changes in the brain, consistent medication is essential.

 

Uzedy's differentiation lies in its proprietary technology that eliminates the need for a separate high-dose initiation or oral supplementation during the initial treatment phase.

 

Previous long-acting injectables required a high-dose loading dose or co-administration of oral medication for a certain period to reach therapeutic concentration levels.

 

However, Uzedy is designed to achieve an effective blood concentration rapidly within 24 hours of administration using a special polymer technology, allowing for a fast onset of therapeutic effect.

 

Professor A of Neuropsychiatry at a tertiary general hospital in Seoul explained, "The long-acting formulation can resolve the medication adherence issue where patients, due to low insight into their illness, stop taking their medication," and added, "Compared to daily oral medications, it maintains stable drug concentration in the blood, which is beneficial for maximizing therapeutic effect and minimizing the occurrence of side effects." Professor A also said, "This drug alleviates the patient inconvenience of having to take pills daily and the social burden of having to expose one's illness to others, thereby assisting with social reintegration and job retention." Risperidone, Uzedy's active ingredient, is a second-generation antipsychotic developed in the 1990s, with long-proven efficacy and safety in clinical settings.

 

With the introduction of Uzedy, the schizophrenia long-acting injectable (LAI) market in Korea is expected to become a four-way competition.

 

Following existing LAIs based on haloperidol decanoate (1st-generation), paliperidone (2nd-generation), and aripiprazole (3rd-generation), the addition of risperidone-based Uzedy is expected to provide diverse treatment options for schizophrenia patients.

 

Given that some existing treatments offer longer dosing intervals than Uzedy, Uzedy's market establishment and competition will be linked to the overall therapeutic standing of risperidone.

 

However, reimbursement listing is essential for Uzedy to expand its influence in the domestic schizophrenia treatment market.

 

Teva-Handok said, "We have a plan for Uzedy's reimbursement and will follow the standard procedure for securing reimbursement after approval." Additionally, improving the perception of the LAI formulation, which currently has a low prescription rate in Korea, will be a challenge for Teva-Handok.

 

Professor A said, "Research indicates that some clinicians avoid prescribing LAIs due to concerns that it might strain the patient-physician relationship or lead to criticism over forced injections," and stressed, "To increase the prescription rate, we need to eliminate this perception and for physicians to provide treatments they believe are necessary with a sense of responsibility." Hee Kyung Ahn, CEO of Teva-Handok, added, "Uzedy is expected to contribute to improving the quality of life for patients who struggle with long-term treatment due to low medication adherence by offering flexible dosing options and a rapid therapeutic effect simultaneously."