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Weekly Drug News Round-Up: December 2, 2015

Empliciti: FDA Approves Second Monoclonal Antibody for Multiple Myeloma

Empliciti activates the body’s immune system to attack and kill multiple myeloma cells Read More...

FDA has approved Bristol-Myers Squibb’s Empliciti (elotuzumab), a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody indicated in combination with lenalidomide (Revlimid) and dexamethasone (a type of corticosteroid) for multiple myeloma in patients who have received one to three prior therapies. In clinical studies, those taking Empliciti plus Revlimid and dexamethasone had a 19.4 month delay in disease progression, compared to 14.9 months in those taking Revlimid and dexamethasone. Common side effects included fatigue, diarrhea, fever, constipation, infection, decreased appetite, cough, and nerve damage.

Fluad Vaccine Cleared for Prevention of Seasonal Influenza

Fluad is manufactured using an egg-based process

Fluad (influenza vaccine, adjuvanted) is an inactivated trivalent influenza vaccine approved for the prevention of seasonal influenza in people 65 years of age and older. Fluad is formulated with the adjuvant MF59, a highly purified version of squalene oil, and is the first seasonal flu vaccine containing an adjuvant. Adjuvants are used in vaccines to enhance or direct the immune response. Hospitalizations and deaths due to flu tend to occur in age groups over 65 years. Clinical studies showed that Fluad induced antibody levels were comparable to the levels induced by another FDA-approved non-adjuvanted trivalent flu vaccine known as Agriflu.

News of Statin Side Effects May Lead to Nonadherence

Stopped prescriptions were linked to a 26% elevated risk of suffering a heart attack over the next four years Read More...

Danish researchers have found a link, but cannot prove, that some patients may have stopped their statins within six months of their first prescription due to negative media on statin side effects. The cholesterol-lowering class of drugs known as statins (i.e., Lipitor, Zocor, or Crestor) is one of the most widely prescribed drug classes in the U.S. Statin side effects may include muscle pain and weakness or a risk of type 2 diabetes, among others. However, experts state that the media often leave out the overwhelmingly positive heart benefits of statins.

Metformin May Not Always Offer Benefit in Diabetes: Study

Stomach side effects were also worse in the type 1 diabetes metformin group Read More...

Metformin is a first-line drug for patients diagnosed with type 2 diabetes, but in overweight teens with type 1 diabetes, metformin plus insulin offers no benefit, according to a new study published in JAMA. In the trial, 140 overweight and obese teens with type 1 diabetes received either metformin or placebo, along with insulin, for six months. Teens taking metformin plus insulin showed no improvement in blood sugar compared to those using placebo plus insulin. However, experts caution that metformin may decrease amount of insulin used and help with weight loss in obese type 1 diabetics, so larger randomized trials may be warranted.

Alternative to Turing’s Daraprim Distributed by Express Scripts

Price gouging may occur with older prescription drugs for rare diseases that have limited manufacturer availability Read More…

Daraprim, an orphan drug used for a rare disease known as toxoplasmosis, used to be affordable. That is until the price rose by 5,000% when acquired by Turing Pharmaceuticals earlier this year. Price gouging has been a concern in the medical and political world as of late, but some industry players are fighting back. Express Scripts, the largest pharmacy benefit manager (PBM) in the U.S., has agreed to distribute a $1-per-pill alternative to the $750-a-pill Daraprim. The new drug alternative is a compound of pyrimethamine and leucovorin and is made by Imprimis Pharmaceuticals.