Last month, the U.S. Food and Drug Administration (FDA) approved a number of new drugs, generics and indications, including several that have been highlighted by the Emerging Therapeutics team:
Jardiance Receives Cardiovascular Indication
Eli Lilly and Boehringer Ingelheim announced on Dec. 2, 2016, that Jardiance® (empagliflozin) is the first diabetes drug indicated by the FDA to decrease the risk of cardiovascular (CV)-related deaths for adults who have both type 2 diabetes and CV disease. In the EMPA-REG OUTCOME® study, fewer patients who took Jardiance along with their usual diabetes and CV drugs died from heart attacks or strokes than patients who took standard drugs with a placebo. Jardiance is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, a class of drugs that lowers blood sugar by blocking its absorption in the kidneys and forcing more to be eliminated in the urine. It was first FDA approved in August 2014 as combination therapy with lifestyle changes to improve glycemic (blood sugar) control for adults who have type 2 diabetes. Recommended dosing for Jardiance is one tablet (either 10mg or 25mg) every morning. Its complete prescribing information is available here.
Generic to Zetia Launched
On Dec. 12, 2016, Par Pharmaceuticals announced the launch of its AB-rated generic to Merck’s Zetia® (ezetimibe) to reduce elevated LDL cholesterol (LDL-C) in patients with high blood cholesterol. Annual sales for Zetia were estimated at $2.6 billion for the 12-month period ending on Sep. 30, 2016. Par also was granted 180 days of generic exclusivity, preventing FDA from approving additional generics until June 2017.
Eucrisa Approved for Atopic Dermatitis
On Dec. 14, 2016, theFDA approved Pfizer’s Eucrisa™ (crisaborole) ointment, 2%. It is the first topical phosphodiesterase 4 (PDE-4) inhibitor indicated to treat eczema (chronic inflammatory skin conditions) in patients two years of age and older. Atopic dermatitis is a common form of eczema. Eucrisa is applied as a thin coating on the affected skin twice a day. Full prescribing information is available here.
Basaglar Now Available
Lilly and Boehringer Ingelheim’s Basaglar® (insulin glargine), the first follow-on to Sanofi’s Lantus® (insulin glargine) was launched in the U.S. on Dec. 15, 2016. It is a long-acting insulin indicated to improve glycemic control for adult and pediatric patients with type 1 diabetes, and for adults with type 2 diabetes. It is supplied in cartons of five KwikPen® devices that each contain 3mL of U-100 (100 units per mL) of Basaglar. Recommended dosing is individualized according to the patient’s blood sugar levels. Basaglar is given as one subcutaneous injection daily at about the same time of day. Full prescribing information can be found here.
Accelerated Approved for Rubraca in Ovarian Cancer
The FDA granted accelerated approval for Rubraca™ (rucaparib – Clovis Oncology, Inc.) on Dec. 19, 2016. It is indicated for ovarian cancer that has progressed despite at least two chemotherapy treatments and that has a deleterious BRAC genetic mutation as confirmed by an FDA-approved diagnostic test. Rubraca is an oral drug with recommended dosing of 600mg twice a day until the cancer worsens or the patient cannot take the drug any longer. Prescribing information is available here.
Spinraza Approved to Treat Spinal Muscular Atrophy
Spinraza™ (nusinersen) was FDA approved on Dec. 23, 2016. It is the first drug indicated to treat spinal muscular atrophy (SMA), a rare genetic condition that causes increasing weakness in muscles. Spinraza will be given intrathecally (directly into the fluid around the spinal cord) by a healthcare provider who is trained to perform spinal procedures. Recommended dosing is three 12mg doses administered at two-week intervals, followed by a fourth dose one month after the third; and then by one dose every four months. Ionis Pharmaceuticals developed Spinraza, which is marketed by Biogen, Inc. Complete prescribing information is here.
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