9 Recent Drug Approvals Techs Should Know
Learn about the new drugs and expanded indications approved by the FDA in September 2015.
Learn about the new drugs and expanded indications approved by the FDA in September 2015.
The FDA recently expanded the use of Sunovion’s anticonvulsant eslicarbazepine acetate (Aptiom).
The drug was initially approved in 2013 as an adjunctive therapy for the treatment of partial-onset seizures, but it is now also indicated as a monotherapy for this purpose.
With this recent nod, Aptiom is currently the only once-daily, non-extended-release antiepileptic drug that can be used alone or in combination with other anticonvulsants to treat partial-onset seizures.
Adverse events associated with the use of Aptiom include dizziness, sleepiness, vision problems, suicidal thoughts, serious skin rash, low sodium levels in the blood, and liver problems. The drug may also decrease the effectiveness of birth control.
On September 3, 2015, the FDA approved a new 60 mg dose of AstraZeneca’s blood thinner ticagrelor (Brilinta).
The drug was initially approved in July 2011 to reduce the rate of thrombotic cardiovascular events such as heart attack in patients with acute coronary syndrome. Like other antiplatelet agents, Brilinta carries a risk of bleeding.
AstraZeneca plans to launch the 60 mg tablets very soon, according to a manufacturer press release. The drug is currently available as a 90 mg dose.
The FDA approved New Haven Pharmaceuticals’ 162.5 mg extended-release aspirin (Durlaza) on September 8, 2015.
The drug is indicated for the secondary prevention of stroke and acute cardiac events such as heart attack in high-risk patients. It is the first and only 24-hour aspirin formulation to receive the FDA’s nod.
While traditional immediate-release aspirin only remains in the blood for about 4 to 6 hours, Durlaza’s extended-release capabilities allow for prolonged absorption and sustained platelet exposure to aspirin.
Like immediate-release aspirin, the use of Durlaza can increase the risk of bleeding and gastric ulceration, and it may cause fetal harm, increased incidence for intracranial hemorrhage in premature infants, stillbirths, and neonatal deaths when administered to pregnant women.
New Haven Pharmaceuticals plans to launch Durlaza in the United States in the fourth quarter of 2015, according to a manufacturer press release.
The FDA expanded the indication of AbbVie’s adalimumab (Humira) on September 10, 2015, approving the injectable drug for the treatment of moderate to severe hidradenitis suppurativa, an inflammatory skin disease.
With this nod, Humira has become the first and only FDA-approved therapy to treat this condition among adults, according to a manufacturer press release.
The drug was previously approved as a treatment for moderate to severe rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, severe ulcerative colitis, and moderate to severe chronic plaque psoriasis.
Adverse events associated with the use of Humira include injection site reactions, upper respiratory infections, headaches, rash, and nausea.
On September 25, 2015, the FDA approved Novo Nordisk’s insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg) 70/30.
The FDA had previously rejected both drugs, but reconsidered them after the manufacturer resubmitted regulatory applications.
Tresiba is indicated for the once-daily treatment of adults with type 1 or 2 diabetes. The drug can be administered subcutaneously at any time of day and dosed based on each individual patient’s needs.
Ryzodeg 70/30 is a mixture of a rapid-acting human insulin analog and long-acting insulin analog approved for the treatment of adults with diabetes mellitus. When combined with mealtime insulin, Ryzodeg can also yield reductions in HbA1c comparable with other approved long-acting or pre-mixed insulin.
Adverse events associated with both products include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain. Like all insulin, the drugs also carry a risk of severe, life-threatening generalized allergy.
The FDA expanded the indication of Boehringer Ingelheim’s tiotropium bromide inhalation spray (Spiriva Respimat) on September 15, 2015.
Initially approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in September 2014, the long-acting muscarinic antagonist is now also indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma.
The most common adverse events associated with the use of Spiriva Respimat in patients with asthma are sore throat, sinus infection, bronchitis, and headache. It is not a treatment for sudden asthma symptoms.
On September 2, 2015, the FDA updated the label of Allergan’s ceftaroline fosamil (Teflaro) to reflect that the drug can now be administered by intravenous infusion in 5 minutes to 1 hour, a shorter infusion time than what was previously approved.
Teflaro, a bactericidal cephalosporin with activity against both Gram-positive and Gram-negative pathogens, is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) in adults.
The drug is currently the only approved cephalosporin with activity against MRSA.
The most common adverse events associated with the use of Teflaro include diarrhea, nausea, and rash.
The FDA approved Forest Laboratories’ cariprazine (Vraylar) on September 17, 2015.
Vraylar is indicated for the treatment of schizophrenia and manic or mixed episodes associated with bipolar disorder. However, the drug is not approved to treat seniors with dementia-related psychosis, and it carries a Boxed Warning informing health care professionals that it may increase the risk of death in these patients.
Adverse effects associated with the use of Vraylar in patients taking the drug for schizophrenia include tremor, slurred speech, and involuntary muscle movements, while additional side effects reported by patients taking the treatment for bipolar disorder include akathisia, dyspepsia, vomiting, drowsiness, and restlessness.
