• No results found

UCB to provide additional information to the US FDA regarding midazolam nasal spray submission (1.4.2019) | Vlaamse Federatie van Beleggers

N/A
N/A
Info
Downloaden
Protected

Academic year: 2022

Share "UCB to provide additional information to the US FDA regarding midazolam nasal spray submission (1.4.2019) | Vlaamse Federatie van Beleggers"

Copied!
2
0
0

Bezig met laden.... (Bekijk nu de volledige tekst)

Download het nu ( 2 pagina )

Hele tekst

(1)

UCB to provide additional information to the US FDA regarding midazolam nasal spray submission

Brussels (Belgium) & Atlanta, Georgia (U.S.) 07:00, 01 April 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter requesting additional information to complete the review of the New Drug Application for midazolam nasal spray, a rescue treatment for acute repetitive seizures (ARS, also known as seizure clusters) in patients with epilepsy. UCB acquired the rights to midazolam nasal spray from Proximagen in June 2018.

The FDA request for additional information is not related to the safety or efficacy data submitted to support the application. As UCB will hold the NDA, the FDA is requiring an update to the New Drug Application to include information related to UCB’s quality systems related specifically to the

regulations governing devices.

UCB will work with FDA to determine next steps and will make sure to provide them with the specific information they need. We look forward to being able to bring this important medicine to patients.

At UCB, we remain committed to delivering value to patients with unmet needs, including those living with uncontrolled seizures.

For further information, UCB:

Corporate Communications France Nivelle,

Global Communications, UCB T +32.2.559.9178,

france.nivelle@ucb.com Laurent Schots, Media Relations, UCB T +32.2.559.92.64, laurent.schots@ucb.com

Investor Relations Antje Witte,

Investor Relations, UCB T +32.2.559.94.14,

antje.witte@ucb.com Isabelle Ghellynck, Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com

Brand Communications Jim Baxter,

Neurology Communications, UCB T+32.2.473.78.85.01

jim.baxter@ucb.com US Communications Allyson Funk

Head of U.S. Communications, UCB T +1.678.365.6321

allyson.funk@ucb.com

(2)

UCB News

UCB News About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Referenties

Download het nu ( PDF - 2 pagina - 130.25 KB )

GERELATEERDE DOCUMENTEN

UCB-FDA Accepts New Drug Application (NDA) to review Midazolam Nasal Spray, an investigational product for the acute treatment of seizure clusters (13.8.2018) | Vlaamse Federatie van Beleggers

• Midazolam Nasal Spray has been granted orphan drug designation by the United States Food and Drug Administration (US FDA) for the rescue treatment of seizures in patients

Hyloris - Announces FDA Acceptance of New Drug Application for Maxigesic® IV in Post-Operative Pain (01.11.2021) | Vlaamse Federatie van Beleggers

The FDA is expected to confirm the Prescription Drug User Fee Act (PDUFA) action date for the filing in due course. The PDUFA date – the date at which the FDA must respond to

UCB - Update on U.S. FDA Review of Biologics License Application (BLA) for bimekizumab (18.10.2021) | Vlaamse Federatie van Beleggers

Application (BLA) for bimekizumab for the treatment of moderate to severe plaque psoriasis by the Prescription Drug User Fee Action (PDUFA) date of October 15, 2021.. The Agency

Acacia Pharma-Update on FDA regulatory review of BARHEMSYS (8.10.2018) | Vlaamse Federatie van Beleggers

Cambridge, UK and Indianapolis, US – 8 October 2018: Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US

UCB and Microsoft Expand Collaboration to Accelerate Drug Discovery and Development (23.02.2021) | Vlaamse Federatie van Beleggers

As several drug discovery activities require the analysis of high-dimensional data sets or multi-modal unstructured information, Microsoft’s platform can support UCB’s

UCB-CIMZIA is Now the First and Only U.S. FDA-Approved Treatment for Non-Radiographic Axial Spondyloarthritis (28.3.2019) | Vlaamse Federatie van Beleggers

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who

UCB-FDA APPROVES EVENITY™ (ROMOSOZUMAB) FOR THE TREATMENT OF OSTEOPOROSIS IN POSTMENOP. (10.4.2019) | Vlaamse Federatie van Beleggers

“After spending 30 years caring for women with osteoporosis and in clinical research, I know that women at high risk of fracture need another therapy that reduces fractures

ACACIA PHARMA RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR BARHEMSYS (3.5.2019) | Vlaamse Federatie van Beleggers

Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other