FDA drug approvals-August 2014
FDA Actions in Brief
A new indication for eltrombopag (Promacta, GlaxoSmithKline) was approved for once-daily use in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.
Abacavir 600 mg, dolutegravir 50 mg and lamivudine 300 mg (Triumeq, ViiV Healthcare) tablets were approved for the treatment of HIV-1 infection.
Diclofenac (Zorvolex, Iroko Pharmaceuticals) capsules were approved for the management of osteoarthritis pain.
Peginterferon beta-1a (Plegridy, Biogen Idec) for the treatment of adults with relapsing forms of multiple sclerosis.
Fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) for maintenance treatment of asthma in patients aged 12 years and older.
Eliglustat (Cerdelga, Genzyme) was approved to the long-term treatment of adult patients with the Type1 form of Gaucher disease, a rare genetic disorder.
The first zinc transporter 8 autoantibody (ZnT8Ab, KRONUS Market Development Associates) test has been allowed to be marketed to help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.
Suvorexant (Belsomra, Merck) was approved for adults with insomnia who have difficulty falling asleep and/or staying asleep. Belsomra is a highly selective antagonist for orexin receptors.
Bevacizumab (Avastin, Genentech, a member of the Roche Group) was approved to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.
A fixed-dose therapy combining canagliflozin and metform hydrochloride (Invokamet, Janssen Pharmaceuticals) in a single tablet was approved to treat adults with type 2 diabetes.
Oritavancin (Orbactiv, The Medicines Company) for injection was approved for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).
Bortezomib (Velcade, Millennium: The Takeda Oncology Company) was approved for the retreatment of adult patients with multiple myeloma who had previously responded to Velcade therapy and relapsed at least 6 months following completion of prior Velcade treatment.
The approved use of alglucosidase alfa (Lumizyme, Genzyme) for treatment of patients with infantile-onset Pompe disease, was expanded to include patients of all ages, including those who are less than aged 8 years. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.
Empagliflozin (Jardiance, Boehringer Ingelheim) tablets were approved as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Olodaterol (Striverdi Respimat, Boehringer Ingelheim) inhalation spray was approved to treat patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema that are experiencing airflow obstruction.
Aflibercept (Eylea, Regeneron) Injection was approved for the treatment of diabetic macular edema.
Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER, Purdue Pharma), an extended-release/long-acting (ER/LA) opioid analgesic was approved to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Idelalisib (Zydelig, Gilead Sciences) was approved to treat patients with 3 types of blood cancers. It has been approved to treat patients whose chronic lymphocytic leukemia (CLL) has relapsed. Used in combination with rituximab (Rituxan, Genentech, a member of the Roche Group), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (comorbidities). Zydelig also has been granted accelerated approval to treat relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Zydelig is meant for patients who have received at least 2 prior systemic therapies.
Fluticasone propionate 50 µg spray (Flonase Allergy Relief, GlaxoSmithKline) was approved as an over-the-counter treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.
The approved use of ibrutinib (Imbruvica, Pharmacyclics) in chronic lymphocytic leukemia (CLL) has been expanded to include patients with the chromosome 17p deletion.
Methotrexate (Rasuvo, Medac Pharma) injection was approved for rheumatoid arthritis, poly-articular-course juvenile idiopathic arthritis and psoriasis.
C1 Esterase Inhibitor [Recombinant] (Ruconest, Salix) was approved for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Immune Globulin Intravenous [Human] (Octagam 10%, Octapharma) for the treatment of adults with chronic immune thrombocytopenic purpura, a platelet disorder that can result in easy or excessive bruising and bleeding.