Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 1 | Issue 18
October 15, 2019

Contributors:
Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD

Clinical Update

First oral GLP-1 treatment for type 2 diabetes receives FDA approval

On Sept. 27, 2019, the U.S. Food and Drug administration (FDA) approved Rybelsus® (semaglutide) oral tablets to improve control of blood sugar levels in conjunction with diet and exercise in adult patients with type 2 diabetes. Rybelsus® is the first FDA-approved oral agent in a class of medicines known as glucagon-like peptide-1(GLP-1) receptor agonists. GLP-1 medications work by slowing sugar production in the liver and increasing insulin production from the pancreas when needed. When compared to placebo and GLP-1 injectable treatments, Rybelsus® achieved significant reduction in hemoglobin A1c levels, which is a measure of blood sugar over time. Rybelsus® achieves similar reductions in hemoglobin A1c levels to other existing GLP-1 medicines but offers patients a non-injectable alternative in this drug category.


Safety First

Apotex Corp. issues voluntary recall on popular acid-reducer medicine

On Sept. 25, 2019, Apotex Corp. announced a precautionary voluntary recall of all pack sizes and formats of ranitidine 75mg and 150mg tablets. Ranitidine, commonly known by its trade name, Zantac®, is an over-the-counter (OTC) product used for relief and prevention of heartburn. Apotex Corp. was alerted by the U.S. FDA that some ranitidine products contained low levels of an impurity that is classified as a probable human carcinogen, known as N-nitrosodimethylamine (NDMA). The announcement came one day after Sandoz Inc. announced a similar recall of ranitidine capsules. On Oct. 2, 2019, the FDA published a press announcement update reassuring the public that they will continue to test ranitidine products from different manufacturers and assess possible impact on patients who have been taking the medication. At this time, the FDA is not calling for individuals to stop taking ranitidine but recommends that patients wishing to discontinue the medicine talk to their health care professional.


From the Industry

Fixed-dose combination of glaucoma agents proves superior to single therapy

A recent study published in the American Journal of Ophthalmology evaluated the efficacy and safety of once-daily administration of a fixed-dose combination (FDC) of netarsudil and latanoprost compared to either drug alone. Netarsudil and latanoprost work through unique mechanisms to lower pressure in the eye, known as intra ocular pressure (IOP). Elevated IOP is a known risk factor for the development of glaucoma, a disease of the optic nerve that can lead to blindness. In the study, 718 participants were randomized to the FDC of both medicines or either drug alone. IOP was measured at weeks two, six and 12. Results of the trial found that the FDC demonstrated acceptable safety and IOP reductions were superior to either drug alone across all time points.


FDA Approvals

Recent FDA Approvals

New Dosage Form: OzobaxTM (baclofen)
Oral solution for the treatment of spasms associated with multiple sclerosis (MS) and patients with spinal cord injuries [9/18/2019 – Orphan Drug – METACEL PHARMA LLC]

New Formulation: potassium phosphates
Intravenous injection indicated for the correction of low phosphorus levels in adults and pediatric patients greater than 12 years of age [9/19/2019 – Priority Review – CMP DEVELOPMENT LLC]

Novel Drug Approval: Rybelsus® (semaglutide)
Oral tablets for the treatment of type 2 diabetes in adult patients in conjunction with diet and exercise [9/20/2019 – Priority Review – NOVO NORDISK INC]


New Generics

New Generics Entering the Marketplace

Orfadin® (nitisinone)
Indication: Hypertyrosinemia, tyrosine protein buildup in the blood
Dosage Form/Strength: 2MG, 5MG, 10 MG Capsule
Average Wholesale Price (AWP)*: Generic =10 MG ($121,623) | Brand = 10MG ($135,144)
*Weight-based dosing using average weight of individuals > 20 years old

Trisenox® (arsenic trioxide)
Indication: Blood and bone marrow cancer
Dosage Form/Strength: 2MG/ML Intravenous Injection
Average Wholesale Price (AWP)*: Generic = 2MG/ML ($225,462) | Brand = 2MG/ML ($260,952)
*Weight-based dosing using average weight of individuals > 20 years old