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Weekly Drug News Round-Up: July 12, 2017

Bristol-Myers Squibb’s Orencia Approved for Treatment of Psoriatic Arthritis

This approval marks the third autoimmune disease use for Orencia Read More...

Orencia (abatacept), a selective costimulation modulator, is used in inflammatory autoimmune diseases like rheumatoid arthritis (RA) and works by interfering with the activity of T-cells, a type of white blood cell. The U.S. Food and Drug Administration (FDA) has now approved a new indication for Orencia, for the treatment of adults with active psoriatic arthritis. The approval was based on results from two controlled trials in which Orencia improved disease activity in patients with high disease activity, tender and swollen joints, and a disease duration of more than seven years, despite other treatments. The safety profile of Orencia was consistent with that seen in RA. Orencia is available in both intravenous and subcutaneous (SC) forms.

FDA Approves Endari for Sickle Cell Disease

According to the NIH, roughly 100,000 people in the U.S. have sickle cell disease Read More...

Sickle cell disease is an inherited disorder which leads to crescent, or "sickle" shaped red blood cells that limit oxygen delivery and lead to severe pain and organ damage. The FDA has approved oral Endari (L-glutamine), an amino acid formulation to relieve pain, swelling and other complications of sickle cell disease. In clinical studies of Endari compared to placebo over 48 weeks, patients who received Endari had fewer hospital visits for pain due to sickle cell crisis (median 3 vs. 4), fewer hospital days (median 6.5 days vs. 11 days), and fewer occurrences of life-threatening acute chest syndrome (8.6% vs. 23.1%). Common side effects of Endari include constipation, nausea, headache, and stomach pain, among others.

Blincyto Granted Full Approval for Advanced Acute Lymphoblastic Leukemia

Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager Read More...

Amgen’s Blincyto (blinatumomab), previously approved on an "accelerated" basis by the FDA, has received full FDA-approval of the supplemental Biologics License Application (sBLA) to include overall survival (OS) data from the Phase 3 TOWER study. The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the TOWER study, Blincyto demonstrated a superior improvement in median OS over standard of care (SOC) chemotherapy, nearly doubling median OS. The study showed that median OS was 7.7 months (95 percent CI: 5.6, 9.6) for Blincyto versus 4 months (95 percent CI: 2.9, 5.3) for SOC.

Prescribed EpiPen Often Not Available When Needed by Kids

Education for patients and families about allergy symptoms and the need to always carry their device is needed Read More...

Injectable epinephrine, found in EpiPen, Adrenaclick, and other brands and generics, is the gold standard treatment for severe allergic reactions that can occur in children. These anaphylactic reactions, often due to foods like peanuts, bee stings, or medications, can be life-threatening. As reported by researchers in the Annals of Allergy, Asthma and Immunology, a medical records review showed that roughly two-thirds of children had a known history of anaphylaxis, and nearly half had been prescribed an EpiPen-type device; however, only two-thirds who received a prescription had the device at the time of the reaction. Recent price reductions should enable patients to more easily afford these products.

Cancer Breakthrough: First CAR-T Cell Gene Therapy Recommended for Approval

Acute lymphoblastic leukemia comprises about a quarter of cancers in children under 15 years old Read More...

A major milestone in cancer treatment was reached today. The FDA Oncologic Drugs Advisory Committee unanimously (10-0) recommended approval of Novartis’ CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). FDA is expected to make its final decision on approval by October 3rd. In CAR T cell therapy, white blood cells (T-cells) are drawn from a patient's blood and genetically reprogrammed to boost recognition and destruction of cancer cells. In addition, Kite Pharma's CAR T agent KTE-C19 for non-Hodgkin lymphoma is at the FDA undergoing review with a decision expected by November 29th.