Friday, April 1, 2016
Facing protocol amendments head-on
Facing protocol amendments head-on
Eli Lilly and Incyte have announced that detailed results of RA-BEACON, a pivotal phase III global study of baricitinib, a once-daily oral treatment currently under regulatory review for the treatment of moderate-to-severe rheumatoid arthritis (RA), now published in the New England Journal of Medicine.
The FDA granted marketing approval for Jazz Pharmaceutical’s Defitelio (defibrotide sodium) for the treatment of adult and pediatric patients with hepatic Veno-Occlusive Disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following Hematopoietic Stem-Cell Transplantation (HSCT).
The FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
A clinical trial in which volunteers were infected with dengue virus six months after receiving either an experimental dengue vaccine developed by scientists from the National Institutes of Health (NIH) or a placebo injection yielded starkly contrasting results. All 21 volunteers who received the vaccine, TV003, were protected from infection, while all 20 placebo recipients developed infection. The study, published in Science Translational Medicine, underscores the importance of human challenge studies, in which volunteers are exposed to disease-causing pathogens under carefully controlled conditions.
The FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
Adocia and Eli Lilly have announced positive topline results from a phase Ib clinical trial under the Adocia-Lilly partnership evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia’s proprietary technology BioChaperone, designed to accelerate insulin absorption.
The FDA has issued an alert for healthcare professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.
The FDA has accepted Roche’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.
AstraZeneca’s global biologics R&D arm, MedImmune, has received Fast Track designation from the FDA for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalized with type A strain influenza. The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.