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Weekly Drug News Round-Up: October 4, 2017

Novo Nordisk Receives FDA Approval for Rapid-Acting Insulin Fiasp

Rapid-acting insulin should mimic the natural physiological insulin response that occurs after meals Read More...

The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s Fiasp (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin for use in type 1 and type 2 diabetes. Fiasp is a new formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption in roughly 2.5 minutes. Fiasp can be dosed at the beginning of a meal or within 20 minutes after starting a meal. Fiasp will be available in a pre-filled pen and a 10 mL vial, and will be priced the same as NovoLog. Copay savings cards and Patient Assistance Programs will be available from the manufacturer.

FDA Approves Lilly’s Verzenio: A Targeted Breast Cancer Treatment

Verzenio works by blocking cyclin-dependent kinases 4 and 6 involved in promoting the growth of cancer cells Read More...

Lilly’s Verzenio (abemaciclib), a CDK 4/6 inhibitor breast cancer treatment, has been FDA-approved. Verzenio is used in 2 patient populations: either with fulvestrant (Faslodex) in patients with HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy; or as monotherapy for patients who previously received endocrine therapy and chemotherapy. In combination with fulvestrant, the median progression-free survival was 16.4 months compared to 9.3 months for the fulvestrant/placebo group. In monotherapy trials, 19.7% of patients taking Verzenio experienced complete or partial shrinkage of their tumors for a median of 8.6 months. Palbociclib (Ibrance) and ribociclib (Kisqali) are other kinase inhibitors approved for metastatic breast cancer.

FDA MedWatch: Potentially Blinding Use of Intraocular Vancomycin

FDA is unaware of any adequate studies showing safety and effectiveness of intraocular vancomycin in preventing endophthalmitis Read More...

Intraocular use of vancomycin, alone or in a compounded drug combining multiple active ingredients such as triamcinolone, moxifloxacin, and vancomycin (TMV), is generally not recommended during cataract surgery because of the risk of hemorrhagic occlusive retinal vasculitis (HORV). HORV is a rare, potentially blinding postoperative complication that has been observed in dozens of cataract surgery patients who have received intraocular vancomycin to prevent postoperative endophthalmitis (swelling of the inside of the eye). Characteristics of HORV include a delayed onset (up to three weeks) of sudden painless decreased vision, intraocular swelling or bleeding, and intraretinal hemorrhage, among others. There is no FDA-approved formulation of intraocular vancomycin.

Fighting Follicular Lymphoma: Newer Drug Adds to the Arsenal

In the U.S. more than 72,000 people are diagnosed with non-Hodgkin lymphoma each year Read More...

A study published in the New England Journal of Medicine (NEJM) this week reports that a newer cancer drug called obinutuzumab (Gazyva), a CD20 monoclonal antibody, typically kept follicular lymphoma cancer under control longer, versus the standard drug rituximab (Rituxan). In the study, about 80% of Gazyva patients were showing no signs of cancer progression or relapse compared to roughly 73% of Rituxan patients after 3 years. Experts state this data does not show that Gazyva is always the better choice, and it may cause more side effects, like severe allergic reactions, than Rituxan. Other follicular lymphoma approvals include Aliqopa (copanlisib) and Zydelig (idelalisib).

Moms-To-Be: Don’t Skip Your Whooping Cough Shot

Babies themselves don't receive whooping cough vaccination until they're 2 months old Read More...

Whooping cough (pertussis) can cause uncontrollable, violent coughing that can make it difficult to breathe. A shocking new study from the the U.S. Centers for Disease Control and Prevention (CDC) reveals that many pregnant women - in fact, about 50% - skipped the whooping cough shot that could protect their newborn between fall 2015 and spring 2016. Tdap vaccination during pregnancy can prevent whooping cough in about 75% of newborns and is 90% effective in preventing serious cases requiring newborn hospitalization, according to the CDC. This data reinforces CDC's recommendation for women to get Tdap vaccine in the third trimester of each pregnancy.