FDA Update: April 2017

Apr 11, 2017
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.
  • Cancer
  • Mutiple Sclerosis
  • Skin Conditions

New Pill Bottle

The U.S. Food and Drug Administration (FDA) approved several important new drugs over the past month. Here are six key updates from Express Scripts’ Emerging Therapeutics team:

Kisqali Approved to Treat Breast Cancer

The FDA approved Kisqali® (ribociclib) on March 13, 2017. Kisqali is indicated as first-line treatment for postmenopausal women who have metastatic or advanced hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer. It selectively inhibits cyclin-dependent kinase (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. It will be used in combination with an aromatase inhibitor, such as anastrozole, exemestane or letrozole. Recommended dosing is on four-week cycles, with 600mg (three tablets) of Kisqali taken once daily every day for 21 days, then stopped for the next seven days. The aromatase inhibitor is taken continually without a break. Kisqali will be distributed through an open network. Complete prescribing information is available here.

Xadago Approved for Parkinson’s Disease

On March 21, 2017, the FDA approved Newron Pharmaceuticals’ Xadago® (safinamide) as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. Treatment with Xadago should be started at 50mg per day, which may be increased to 100mg per day, if needed. According to US WorldMed, the company that will market the drug in the U.S., availability and pricing information are not yet available. Prescribing information is here.

Bavencio Approved for Merkel Cell Carcinoma

On March 23, 2017, EMD Serono and Pfizer received approval from the FDA for Bavencio® (avelumab) for the treatment of adult and pediatric patients 12 years of age and older with metastatic Merkel cell carcinoma (mMCC). Bavencio is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. Recommended dosing is 10mg/kg as an intravenous (IV) infusion every 2 weeks. Bavencio was launched upon approval. Full prescribing information can be found here.

Zejula Approved for Recurring Ovarian Cancer Treatment

Tesaro, Inc. received priority-review approval for Zejula (niraparib) from the FDA on March 27, 2017. It is indicated for maintenance treatment of women who have responded at least partially to platinum-based chemotherapy for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Although it is a poly ADP-ribose polymerase (PARP) inhibitor, Zejula does not require testing for a biomarker, such as BRCA gene mutations, like other PARP inhibitors do. Recommended dosing is 300mg (three capsules) orally once a day until the cancer worsens or side effects are unbearable. Launch is planned for late in April and cost will not be disclosed until then. Distribution will be through a limited network. Full prescribing information is available here.

Dupixent Approved for Atopic Dermatitis

Dupixent® (dupilumab) was approved by the FDA on March 28, 2017 for treating adults who have moderate-to-severe atopic dermatitis that is not responding to topical therapy. Atopic dermatitis is a chronic inflammatory disease that results in cracked, dry, itchy or oozing skin. Dupixent is an interleukin-4 alpha receptor (IL-4Rα) blocker — an antibody that disrupts the inflammatory process. Dupixent will be given as subcutaneous injections. After the first dose of 600mg (two injections at the same time but at different injection sites), recommended dosing is 300mg once every two weeks. It can be used along with topical steroids, but the concurrent use of topical calcineurin inhibitors with Dupixent should be reserved for sensitive skin, such as the face or genital areas. Jointly developed by Sanofi and Regeneron, Dupixent will be available through open distribution late in March. It will be dispensed in pre-filled, single-dose syringes. Prescribing information is available here.

Ocrevus Approved for Multiple Sclerosis

Ocrevus (ocrelizumab) injection for intravenous (IV) use was FDA approved on March 28, 2017, to treat both primary progressive multiple sclerosis (PPMS) and relapsing forms of the disease (RMS). The first drug approved for treating PPMS, Ocrevus is a monoclonal antibody. It disrupts the activity of CD20-positive B cells, which play a role in damaging nerve cells (axons) and their coverings (myelin sheaths). Its launch is expected within two weeks at an annual cost of $65,000. Recommended dosing is one infusion of 600mg given by a health professional every six months after the first two doses of 300mg, each administered two weeks apart. Prescribing information for Ocrevus is available here.

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