Phase 3b

Phase 3b

The period of time between submission for approval of a new drug and receipt of marketing authorisation.

Phase 3B

A subcategory of a Phase-3 clinical trial, performed near the time of approval to accumulate additional findings which and may be required as a condition of regulatory authority approval. Dossier review may continue while associated Phase-3B trials are conducted.
References in periodicals archive ?
Teva announced that results from the Phase 3b FOCUS study, which examined fremanezumab versus placebo in adult migraine patients who previously experienced inadequate responses to two to four classes of preventive treatments, were published online ahead of print in The Lancet.
The ongoing Phase 3b EXPEDITION-8 study is evaluating the safety and efficacy of MAVIRET in treatment-naive chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6).1 The results have been reported for GT1, 2, 4, 5, and 6 (n=280) patients.
The marketing authorisation is supported by data from the ongoing Phase 3b EXPEDITION-8 study, which showed that with eight weeks of Maviret, 97.9 % (n=274/280) of GT1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12).
The Phase 3b HOPE study was a follow-on to the NIH-funded ASPIRE clinical trial.
As announced earlier this year, Biogen has initiated the ongoing Phase 3b NOVA study (NCT03689972) to assess the efficacy of every six-week natalizumab dosing intervals in people with relapsing-remitting MS.
Rheinmetall MAN Military Vehicles Australia will deliver more than 1000 high mobility logistics trucks and more than 800 modules to the ADF under the new program, which is an extension of the current LAND 121 Phase 3B Project.
A report from the phase 3b, randomized, placebo-controlled, 250-patient LIBERATE trial showed that the week 16 Psoriasis Area Severity Index (PASI) 75 response rate was 39.8% with apremilast, 48.2% with etanercept (Enbrel), and 11.9% with placebo.
The Phase 3b BESIDE study enrolled 2,174 patients to evaluate the efficacy, safety and tolerability of mirabegron 50 mg as an add-on therapy with solifenacin succinate 5 mg versus solifenacin succinate 5 mg and 10mg alone in OAB.
For patients with chronic hepatitis C and hepatitis B virus coinfection, 12 weeks of ledipasvir/sofosbuvir therapy achieved a 100% sustained viral response rate without causing liver failure or death in a phase 3b, multicenter, open-label study.
(NYSE: DQ) (NYSE: DQ), a manufacturer of high-purity polysilicon for the global solar PV industry, has received approval from the board of directors for its Phase 3B expansion plan for its polysilicon facilities in Xinjiang.
The Australian Defence Force (ADF) has received its first medium and heavy-duty trucks in Brisbane, with coatings supplied by Axalta Coating Systems, under the Land 121 Phase 3B Defence program.
A phase 3b open-label expanded access program (EAP) provided patients with access to radium-223 prior to regulatory approval and evaluated its safety and efficacy in patients with progressive bone-predominant mCRPC.