Monday, December 20, 2021 4:30:19 PM
Mon, December 20, 2021, 11:02 AM
In this article:
GBT
+2.32%
Explore the topics mentioned in this article
Global Blood Therapeutics, Inc. GBT announced that the FDA has granted accelerated approval to its supplemental new drug application (“sNDA”) for Oxbryta (voxelotor) to treat sickle cell disease (“SCD”) in children aged four to less than 12 years.
The regulatory body also approved the new drug application (“NDA”) for Oxbryta tablets for oral suspension – a new dispersible, once-daily tablet dosage for patients aged four to less than 12 years, as well as for older patients who have difficulty swallowing whole tablets.
Oxbryta is currently approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above.
The FDA nod for the sNDA was based on data from the phase IIa HOPE-KIDS 1 study, which evaluated Oxbryta in the given patient population. Data from the same showed that weight-based treatment with the dispersible tablet formulation of Oxbryta led to rapid and sustained improvements in hemoglobin. Concurrent reduction of hemolysis or red blood cell destruction was also demonstrated in the study.
Shares of Global Blood have plunged 29.5% so far this year compared with industry’s decrease of 19%.
Recent GBT News
- GROUPE BMTC INC. ANNONCE L'ACQUISITION D'UN CENTRE DE DISTRIBUTION À TERREBONNE AFIN DE GÉNÉRER DES REVENUS LOCATIFS À LONG TERME • PR Newswire (Canada) • 04/15/2024 11:30:00 PM
- BMTC GROUP INC. ANNOUNCES THE ACQUISITION OF A DISTRIBUTION CENTER TO GENERATE LONG-TERM RENTAL INCOME • PR Newswire (Canada) • 04/15/2024 11:30:00 PM
- GROUPE BMTC INC. ANNONCE LE RENOUVELLEMENT DE SON OFFRE DE RACHAT DANS LE COURS NORMAL DES ACTIVITÉS VISANT SES ACTIONS ORDINAIRES • PR Newswire (Canada) • 04/10/2024 11:30:00 PM
- BMTC GROUP INC. ANNOUNCES THE RENEWAL OF ITS NORMAL COURSE ISSUER BID TO ACQUIRE COMMON SHARES • PR Newswire (Canada) • 04/10/2024 11:30:00 PM
- GROUPE BMTC INC. ANNONCE SES RÉSULTATS FINANCIERS POUR LA PÉRIODE DE NEUF MOIS TERMINÉE LE 31 OCTOBRE 2023 • PR Newswire (Canada) • 12/12/2023 12:30:00 AM
- BMTC GROUP INC. ANNOUNCES FINANCIAL RESULTS FOR THE NINE MONTH PERIOD ENDED OCTOBER 31st, 2023 • PR Newswire (Canada) • 12/12/2023 12:30:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM