FDA Update: October 2017

Oct 12, 2017
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Express Scripts’ Emerging Therapeutics team is highlighting some key updates among the many new drugs, additional indications and generic approvals last month.

Austedo Approved for Tardive Dyskinesia

The U.S. Food and Drug Administration (FDA) approved Teva’s Austedo® (deutetrabenazine) to treat tardive dyskinesia on Aug. 30, 2017. Tardive dyskinesia is a side effect from long-term use of some drugs — primarily antipsychotics. It typically involves uncontrollable movements of the face, including the eyes, jaw, lips and tongue; but it also can affect other parts of the body. Austedo originally was approved in April for adult patients who have a similar condition, chorea, which is caused by Huntington’s disease. It is believed to modulate signals between nerves by temporarily decreasing the amounts of monoamines, such as dopamine and serotonin, within the brain. To treat tardive dyskinesia, the recommended starting dose is 12mg each day, which may be increased at weekly intervals to a maximum of 48mg daily. A boxed warning on Austedo’s label cautions that depression and suicidality may be increased among patients taking it. Prescribing information for it is available here.

FDA Approves Mvasi, a biosimilar to Avastin

On Sept. 14, 2017, the FDA approved Allergan and Amgen’s Mvasi™ (bevacizumab-awwb), a biosimilar to Genentech’s Avastin®. Mvasi is approved for treating metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer. It was not approved for three Avastin indications (ovarian, fallopian tube, and primary peritoneal cancer) because they are still protected by Orphan Drug Exclusivity (ODE). The dose of Mvasi varies depending on the indication. While launch plans for Mvasi are unknown, it likely will be delayed until July 2019. Full prescribing information is available at here.

Aliqopa Approved for Follicular Lymphoma

Also on Sept. 14, 2017, Bayer received FDA approval of Aliqopa™ (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. The recommended dose of Aliqopa is 60mg administered as a one-hour intravenous (IV) infusion on Days 1, 8 and 15 of a 28-day treatment cycle. Bayer is expected to launch Aliqopa immediately. It will only be available through hospitals and clinics; Accredo will not be dispensing Aliqopa. Full prescribing information can be found here.

Privigen Approved for Chronic Inflammatory Demyelinating Polyneuropathy

The FDA approved CSL Behring’s Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] on Sept. 14, 2017, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. CIDP is a progressive autoimmune disorder that causes weakness, numbness and tingling of the arms and legs due to damaged myelin sheath (protective covering) of the peripheral nerves. Approximately 40,000 patients in the U.S. have CIDP. Privigen was originally approved in 2007; it is also indicated to treat primary humoral immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in patients 15 years of age and older. Privigen is administered by intravenous (IV) infusion. Full prescribing information can be found here.

Trelegy Ellipta Approved

The first inhaler that contains three medications for maintenance treatment of chronic obstructive pulmonary disease (COPD) was approved by the FDA on Sept. 18, 2017. Trelegy™ Ellipta®, jointly developed by GlaxoSmithKline and Innoviva, contains a corticosteroid (fluticasone furoate, 100mcg), a long-acting muscarinic antagonist (umeclidinium, 62.5mcg) and a long-acting beta2-adrenergic agonist (vilanterol, 25mcg) in a dry-powder inhaler. It is indicated for patients who already are using some of the included drugs, but who need additional control of airway obstruction or worsening COPD. Dosing is once daily. Like other products that contain a beta2-agonist such as vilanterol, the labeling includes a boxed warning that Trelegy Ellipta may increase the chances of death if it is used by an asthma patient. GlaxoSmithKline plans to release it in the U.S. soon. Its complete prescribing information is available here.

Verzenio Approved to Treat Breast Cancer

On Sept. 28, 2017, the FDA approved Eli Lilly’s Verzenio™ (abemaciclib) for use in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. It also is approved as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. Verzenio selectively inhibits cyclin-dependent kinases (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. The recommended starting dose in combination with fulvestrant is 150mg twice daily; as monotherapy, the recommended starting dose is 200mg twice daily. Lilly plans on launching Verzenio within the next two weeks. It will be available through a limited network of specialty pharmacies that includes Accredo. Full prescribing information can be found here.

New Rapid-Acting Insulin Approved

The FDA approved Novo Nordisk’s rapid-acting insulin, Fiasp® (insulin aspart injection) 100Units/mL, on Sept. 29, 2017. It is indicated to manage blood sugar levels for adults with either type 1 or type 2 diabetes. Because it has been modified to increase absorption, the effects of Fiasp may begin as soon as 20 minutes after injection. Novo Nordisk plans to price Fiasp evenly with its NovoLog® (insulin aspart), but it has not yet announced a date for Fiasp’s release. Recommendations are to inject Fiasp before a meal or within 20 minutes of beginning to eat. It will be dispensed in 10mL multi-dose vials and pre-filled FlexTouch® pen devices. For full prescribing information, please click here.

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