6 Recent FDA Approvals for Techs to Know
Learn about the new drugs and expanded indications approved by the FDA in January 2016.
Learn about the new drugs and expanded indications approved by the FDA in January 2016.
1. Animas Vibe
The FDA expanded the indication of the Animas Vibe insulin pump and continuous glucose monitoring system on January 11, 2016, allowing it to be used by children aged 2 to 17 years.
The system, which was initially approved in December 2014 for the management of diabetes in insulin-requiring adults, is now the only product of its kind to receive the FDA’s nod for this purpose in patients as young as 2 years.
Animas Vibe uses Dexcom G4 Platinum CGM technology and includes features such as waterproof durability, customizable alerts, and a long-wear sensor.
2. Botox
The FDA also expanded the indication of Allergan’s onabotulinumtoxinA (Botox) on January 22, 2016, approving it as a treatment for lower limb spasticity in adults.
Previously approved in April 2015 for the treatment of upper limb spasticity, Botox is now the first and only FDA-approved neurotoxin to treat both forms of limb spasticity.
Adverse events associated with the use of Botox include dry mouth, injection site discomfort, and tiredness. Additionally, more serious side effects related to allergic reactions—such as rash, itchy welts, wheezing, and dizziness— have also been reported.
3. Cosentyx
On January 15, 2016, the FDA expanded the indication of Novartis’ secukinumab (Cosentyx), approving it as a treatment for adults with either active ankylosing spondylitis or active psoriatic arthritis. Both conditions are chronic inflammatory diseases that affect the joints and spine, and they can potentially cause irreversible damage if not properly treated.
Cosentyx, a monoclonal antibody that selectively neutralizes interleukin-17A in the body, was initially approved in January 2015 for the treatment of moderate-to-severe plaque psoriasis in adults.
The most common adverse events associated with Cosentyx include diarrhea and upper respiratory infections. Serious allergic reactions have also been observed in patients treated with the drug.
The FDA approved a new delayed-release formulation of Takeda Pharmaceuticals’ dexlansoprazole (Dexilant SoluTab) on January 28, 2015.
This proton pump inhibitor (PPI) is indicated for the treatment of heartburn associated with gastroesophageal reflux disease (GERD). The melt-in-your-mouth drug can also be used for the maintenance of healed erosive esophagitis and heartburn in adults aged 18 years and older.
This new formulation of Dexilant was designed with dual delayed-release technology that allows patients to either swallow the medication whole with water, or simply let the tablet melt in their mouths without water or chewing.
Adverse events associated the drug’s use include abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. Like all PPIs, Dexilant SoluTab also carries a risk of Clostridium difficile-associated diarrhea and osteoporosis-related fractures of the hip, wrist, or spine.
On January 21, 2016, the FDA approved Eli Lilly’s Humulin R U-500 insulin human injection (KwikPen), a pre-filled device containing a highly concentrated formulation of insulin.
The device is indicated for the management of type 1 and type 2 diabetes in patients who require more than 200 units of insulin per day.
The Humulin R U-500 KwikPen is the first FDA-approved device designed specifically for the administration of U-500 insulin; Humulin R U-500 was previously available in only a vial, which was either administered via syringes meant for U-100 insulin or a tuberculin syringe that required conversion to the appropriate syringe unit markings.
As with all insulins, the most common adverse effect associated with the use of the Humulin R U-500 KwikPen is hypoglycemia. The device is contraindicated in patients hypersensitive to Humulin R U-500, and it should not be used during episodes of hypoglycemia.
6. Omnigraft Dermal Regeneration Matrix
The FDA expanded the indication of Integra LifeSciences’ Omnigraft Dermal Regeneration Matrix on January 7, 2016, approving the device for the treatment of diabetic foot ulcers that last longer than 6 weeks and do not involve exposure of the joint capsule, tendon, or bone.
Omnigraft was previously approved for the treatment of life-threatening burns when a skin graft is not possible, as well as for the treatment of patients undergoing reconstructive surgery for burn scars.
The device is placed over the ulcer, where it aids in the growth of skin and tissue, and it should be used in conjunction with standard diabetic ulcer care.
Adverse events associated with the use of Omnigraft include infections, increased pain, swelling, nausea, and new or worsening ulcers. The device—which is made of silicone, cow collagen, and shark cartilage—should not be used in patients who are allergic to cow collagen or chondroitin, or in those who have infected wounds.
