The FDA has approved mipomersen (Kynamro – Genzyme) and lomitapide (Juxtapid – Aegerion), each in addition to a low-fat diet and other lipid-lowering medications, to reduce cholesterol levels in patients with homozygous familial hypercholesterolemia (HoFH).

The FDA has approved teduglutide (te due’ gloo tide; Gattex – NPS), a recombinant DNA analog of glucagon-like peptide-2 (GLP-2), for treatment of short bowel syndrome (SBS) in adults who are dependent on parenteral support.

The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).

A patient-controlled fentanyl iontophoretic transdermal system (Ionsys – The Medicines Company) is now available for short-term management of acute postoperative pain in adults requiring opioid analgesia in the hospital. Before using Ionsys, patients must be titrated to a comfortable level of analgesia with another opioid formulation.

The FDA has approved rolapitant (Varubi – Tesaro), an oral substance P/neurokinin 1 (NK₁) receptor antagonist, for use with other antiemetics to prevent delayed nausea and vomiting associated with cancer chemotherapy in adults. It is the third substance P/NK₁ receptor antagonist to be approved in the US; aprepitant (Emend) and netupitant (only available in combination with the 5-HT₃ receptor antagonist palonosetron as Akynzeo) were approved earlier for prevention of both acute and delayed chemotherapy-induced nausea and vomiting.

The FDA has approved plecanatide (Trulance – Synergy), a guanylate cyclase-C receptor agonist, for treatment of chronic idiopathic constipation (CIC) in adults. Linaclotide (Linzess), another guanylate cyclase-C receptor agonist, and lubiprostone (Amitiza), a chloride channel activator, were approved earlier for treatment of CIC in adults.

The FDA has approved revefenacin (Yupelri – Mylan/Theravance Biopharma), a long-acting antimuscarinic agent (LAMA) administered once daily by standard jet nebulizer, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Revefenacin is the second nebulized LAMA to be approved for this indication; glycopyrrolate (Lonhala Magnair), which is administered twice daily with a portable handheld nebulizer, was the first.

The FDA has approved cyclosporine 0.09% ophthalmic solution (Cequa – Sun) to increase tear production in patients with keratoconjunctivitis sicca (dry eye disease). Restasis, a 0.05% cyclosporine emulsion, was approved in the US in 2003 for the same indication.

The FDA has approved an intracameral implant containing the prostaglandin analog bimatoprost (Durysta – Allergan) for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Bimatoprost is also available in 0.01% (Lumigan) and 0.03% (generics) ophthalmic solutions for the same indication and in a 0.03% solution (Latisse, and generics) for eyelash enhancement. Durysta is the first ocular implant to become available in the US for treatment of glaucoma.

The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).