Tags : FDA approval

AstraZeneca and the US NIAID Report Results of Fasenra (benralizumab)

Shots: The P-II (NCT02130882) study involves assessing of Fasenra (benralizumab,30mg, q4w) vs PBO in 20 patients with HES who had at least 1,000 eosinophils/µL of blood The P-II (NCT02130882) clinical study results: @12wks. reduction in absolute blood eosinophil counts >50% (90% vs 30%); @48wks.maintained reduction in eosinophil counts (74%); patients taper off other HES therapies […]Read More

Roche’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) Receives FDA’s Approval for

Shots: The approval is based on three P-III study (HannaH, SafeHER, PrefHER) results assessing Herceptin Hylecta (SC) + CT vs Herceptin (IV) + CT in neoadjuvant and adjuvant patients with HER2-positive early breast cancer P-III HannaH, SafeHER, PrefHER study: pCR (absence of invasive cancer cells in breast) (45.4% vs 40.7%); mean level of trastuzumab (78.7mcg/ml […]Read More

Insmed Receives FDA Approval of Arikayce to Treat Mycobacterium Avium

Shots: The approval is based on results of ongoing P-III CONVERT study conducted at 18 countries with 125 sites assessing Arikayce + guideline-based therapy (GBT) vs GBT alone with refractory nontuberculous mycobacterial (NTM) lung disease caused by MAC P-III CONVERT study Results: ARIKAYCE+GBT reduced evidence of NTM lung disease caused by MAC in sputum @6 […]Read More

Teva’s AJOVY Receives FDA Approval for the Treatment of Migraine

Shots: AJOVY (remanezumab-vfrm) is evaluated in two P-III trial enrolling patients with disabling migraine, administering AJOVY alone and in combination with oral preventive treatments, showing reduction in monthly migraine days in 12 wks. duration having injection site reactions as adverse effects The US Wholesale Acquisition Cost (WAC) of AJOVY for monthly and the quarterly dose […]Read More

AstraZeneca’s Lumoxiti Receives FDA approval for the Treatment of R/R

Shots: The approval is based on P-III ‘1053’ trial conducted across 34 sites in 14 countries assessing Lumoxiti (moxetumomab pasudotox-tdfk) in patients with r/r HCL, testing its safety, efficacy, immunogenicity and PK P-III ‘1053’ trial (N=80) results: ORR (75%); DOR (30%); CR (41%); PRR (34%); hematologic remission rate (80%) Lumoxiti (CD22-directed cytotoxin) novel treatment in […]Read More

Eisai and Merck Annouces the US FDA Approval of Lenvima

Shots: Approval is based on positive results of Ph III REFLECT study showing improved OS, PFS and ORR REFLECT results (Lenvima vs Sorafenib): mOS (13.6 vs 12.3 mos), mPFS (7.3 vs 3.6 mos); ORR (41% vs 12%) with AE ≥20% patients & SAEs ≥2%   Lenvima has been approved in Japan in H1’18 for HCC […]Read More

Teva Receives US FDA Approval for Generic Version of Epipen

Shots: Teva’s EpiPen and EpiPen Jr (epinephrine) auto-injector will be used to treat allergic reaction including anaphylaxis in adults and pediatric patients weighing >33 pounds The US FDA approval is prompted to lower cost along with safety and effectiveness for patients EpiPen will be marketed in 0.3 mg and 0.15 mg doses  Click here to […]Read More