FDA approves innovative Teva schizophrenia drug

Teva  credit: Cineberg/Shutterstock
Teva credit: Cineberg/Shutterstock

UZEDY was developed together with MedinCell's copolymer technology.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and MedinCell (Euronext: MEDCL) have announced that the US Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.

Teva president and CEO Richard Francis said, "UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse. The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years."

MedinCell CEO Christophe Douat added, "The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit. We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY. Our technology reaching commercial stage marks the start of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all our employees and shareholders."

The Wholesale Acquisition Cost for UZEDY ranges from $1,232 to $3,080 per month depending on dosage strength. Actual costs for individual patients are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Teva is committed to helping patients who have been prescribed UZEDY access their medication and provide patient support specialists to help with access and reimbursement, prescription pull-through and patient assistance. Savings on out-of-pocket costs may vary depending on the patient’s insurance provider and eligibility for participation in the co-pay assistance program.

UZEDY will be available in the US in the coming weeks.

Teva's share price jumped 4.86% on the TASE yesterday and is up a further 0.76%. On Wall Street the share price rose 2.46% on Friday to $8.43, giving a market cap of $9.697 billion. The share price is up a further 0.92% in premarket trading.

Published by Globes, Israel business news - en.globes.co.il - on May 1, 2023.

© Copyright of Globes Publisher Itonut (1983) Ltd., 2023.

Teva  credit: Cineberg/Shutterstock
Teva credit: Cineberg/Shutterstock
Tel Aviv light rail Light rail fares in Israel jump 33.3%

Bus fares will also rise 33.3% after the 2025 budget is passed.

Quantum Machines founders credit: Eyal Izhar Israeli co Quantum Machines raises $170m

Sources say that the company's valuation, which before the latest round was $520 million, has now risen to $670 million.

Pay cuts illustration: Shutterstock Treasury plans pay cuts for doctors, teachers, and civil servants

The move is intended to ensure that the budget savings target of NIS 5 billion shekels in 2025 is achieved, as part of efforts to reduce the state budget deficit.

Shekel credit: Shutterstock Vladirina 32 Shekel weakens after BoI rate call

Poria Financial Planning chairman Or Poria: There is growing uncertainty over the collapse of the hostage deal, and the increasing probability of renewed fighting in the south.

Daniel Aronovitz credit: Joseph Laor Insight Partners: $6b and still investing in Israel

Insight Partners newly appointed Israel partner Daniel Aronovitz tells "Globes" about the US firms plans for Israel and reveals the huge extent of past investment.

Bank of Israel Governor Amir Yaron credit: Eyal Izhar, Tali Bogdansky BoI Governor: We hope for two rate cuts in second half

Bank of Israel Governor Prof. Amir Yaron tells "Globes" he remains concerned about inflation, higher demand than supply, and real estate balloon loans.

Bank of Israel Governor Prof. Amir Yaron credit: Yossi Cohen BoI keeps rate unchanged for ninth consecutive time

The Bank of Israel Monetary Committee reiterated: the interest rate path will be determined in accordance with the convergence of inflation to its target.

Supervisor of Banks Daniel Hahiashvili credit: Yossi Cohen Regulator opposes Israeli banks increasing dividends

Supervisor of Banks, Daniel Hahiashvili is reportedly reluctant to let banks increase their dividend distribution, from a ceiling of 40% of profits towards 50%.

Metro credit: Bar Lavi Metro dispute over station entrances to delay tenders

NTA believes stations only need one entrance while the Israel Planning Administration says several are necessary.

Declining tech industry pay  credit: Ussama Azam Unsplash Tech salaries in Israel falling with jobs harder to find

Despite inflation tech salaries are declining, the Central Bureau of Statistics reports.

Tel Aviv credit: Shutterstock New Tel Aviv master plan massively boosts building rights

The plan, set to be approved for deposit, adds 11.3 million square meters of housing, 6.1 million square meters of office space and allows construction of 80-floor buildings in certain places.

Israeli apartments Credit: Shutterstock Apartments sold and rented

A selection of recent real estate deals in Israel in Kfar Saba, Even Yehuda, Rishon Lezion, Hadera, Haifa and Tzfat.

Jerusalem's Midtown project credit: DBLD architects Foreign residents dominate Jerusalem city center housing market

Wealthy foreign residents are increasingly pricing residents out of the market in central neighborhoods, as ghost apartments haunt the city.

Egyptian tanks in Sinai near Rafah credit: Reuters Mohamed Abd El Ghany Egyptian military violations in Sinai concern Israel

President Donald Trump's relocation plan for Gazans is further straining fraught relations between Israel and Egypt. "Globes" examines whether it could spark a war.

Yitzhak Tshuva credit: Gidon Levy and Tali Bogdanovsky Isracard shareholders approve acquisition by Delek

For the deal to go through, approval is now needed from the Supervisor of Banks and the Israel Competition Authority.

Air Canada Photo: Shutterstock Air Canada to resume Israel flights in June

The Canadian airline will resume Toronto-Tel Aviv flights on June 8 and Montreal-Tel Aviv flights in August.

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018