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Weekly Drug News Round-Up: March 23, 2016

FDA Approves Teva’s Cinqair to Treat Severe Asthma

Cinqair reduces eosinophils, a type of white blood cell that contributes to asthma development Read More...

Today the U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical's Cinqair (reslizumab) as an adjunct for the maintenance treatment of severe asthma in adults not well-controlled on their current asthma medications. Cinqair (reslizumab) is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa). It is given once every four weeks via intravenous infusion in a clinical setting prepared to manage anaphylaxis. In studies, patients receiving Cinqair had fewer attacks, a longer time to first attack, and improvement in lung functions tests. Common side effects included anaphylaxis, cancer, and muscle pain. Nucala (mepolizumab) is GSK’s IL-5 antagonist also for severe asthma.

FDA Clears Lilly’s Taltz Injection for Plaque Psoriasis

Common side effects were injection site reactions, upper respiratory tract infections, nausea, and fungal skin infections Read More...

Psoriasis is a chronic autoimmune disease in which skin cells are replaced at a quick rate leading to raised plaques that are flaky, red, and itchy. This week, FDA approved Eli Lilly's Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. Taltz is a humanized interleukin-17A antagonist. In pivotal clinical trials including over 3,800 patients, 87 to 90 percent of patients treated with Taltz saw a significant improvement in their condition at 12 weeks. Cosentyx (secukinumab) was the first IL-17 inhibitor, now approved for the treatment of plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.

Anthim Approved for Inhalational Anthrax

Efficacy was determined in animal studies while safety was assessed in humans Read More...

Late last week, FDA approved Anthim (obiltoxaximab) for inhalational Anthrax, a rare disease that can lead to massive tissue injury and death caused by breathing in the spores of the bacterium Bacillus anthracis. Anthrax is also a potential bioterrorism threat. Anthim is a monoclonal antibody that neutralizes toxins produced by B. anthracis and is used in combination with appropriate antibacterial drugs (levofloxacin, ciprofloxacin and doxycycline). It is given as a single IV infusion. Frequently reported side effects were headache, itching, upper respiratory tract infections, cough, nasal congestion, hives, and infusion site reactions. Anaphylaxis may also occur.

Bayer's Kovaltry Wins FDA Approval for Hemophilia A

Kovaltry may offer some patients a twice weekly prophylaxis option Read More...

Hemophilia A is an inherited blood coagulation disorder characterized by missing or reduced factor VIII, a protein the body needs to form blood clots and prevent bleeding. The FDA has approved Kovaltry (antihemophilic factor [recombinant]), a human DNA sequence derived Factor VIII concentrate indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A. The approval of Kovaltry is based on results from the LEOPOLD clinical trials Kovaltry is administered via intravenous infusion up to two or three times per week. The most common side effects reported during clinical trials were headache, fever, and itchy rash.

Boxed Safety Alerts Added to Prescription Opioid Class

FDA policies are aimed at reversing the epidemic, yet providing patients in pain access to relief Read More...

Just one week after the CDC released prescribing guidelines for opioid painkillers, the FDA has released new safety updates and a boxed warning to highlight the risk for abuse, addiction, overdose, and death for immediate-release (IR) products. Opioids include prescription narcotic analgesics such as oxycodone, hydrocodone and morphine. New labeling states IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternatives are inadequate or not tolerated. The new warning includes various information, including pregnancy precautions, dose, patient monitoring, and safe discontinuation. Class-wide labeling changes for extended-release/long-acting (ER/LA) forms of opioid analgesics were implemented in 2013.