Pulse Newsletter

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

Volume 1 | Issue 5
April 1, 2019

Contributors:
Chief Author: Kevin Lavery, PharmD ‘19
Editor: Dana Ranallo, PharmD

Clinical Update

HIV is reported cured in a second patient, a milestone in the global AIDS epidemic

For just the second time since the global epidemic began, a patient appears to have been cured of infection with Human Immunodeficiency Virus (HIV), the virus that causes Acquired Immunodeficiency Syndrome (AIDS). Although the first known patient was cured of HIV nearly 12 years ago, researchers have been unsuccessful in their attempts to replicate the outcome until now. The primary contributor that led to the functional cure involved conducting a bone-marrow transplant. However, this is unlikely to be a realistic treatment due to associated risks such as harsh side effects and transplant risks. We are fortunate to have targeted and robust treatments to treat and control HIV however, “...this will inspire people that cure is not a dream” per Dr. Annemarie Wensing, a virologist at the University Medical Center Utrecth in the Netherlands.


Safety First

Safety trial finds increased risk of blood clots in the lungs and death with high dose tofacitinib

The FDA has released a Safety Communication alerting health care professionals and patients about a safety signal seen in a post marketing trial in patients with rheumatoid arthritis (RA) who were taking Xeljanz®/Xeljanz XR® (tofacitinib) 10 mg twice daily. The Data Safety Monitoring Board found an increased risk of blood clots in the lungs and higher rates of mortality in patients taking a 10 mg twice daily dose of tofacitinib compared to patients treated with either tofacitinib 5 mg twice daily or a tumor necrosis factor inhibitor (TNFi). Of note, the FDA has not approved tofacitinib 10 mg twice daily for RA; this dose is only FDA-approved for patients being treated for ulcerative colitis (UC).


From the Industry

Major U.S. study finds Apple Watch capable of detecting heart issues

Preliminary results from the Apple Heart Study, an 8-month trial conducted by researchers from the Stanford University School of Medicine, indicate that the Apple Watch may have the ability to detect irregular heart rhythms. Throughout the study period, about 0.5% (about 2,000 people) of the more than 400,000 participants wearing Apple Watches were sent irregular heart rhythm notifications which may be a sign of atrial fibrillation, also referred to as “a-fib” by healthcare providers. Additionally, those who received the notification were also directed to receive a telehealth consultation with a doctor and an electrocardiogram (ECG) patch to further monitor their heart health. Of the participants who agreed to wear the ECG, about 34 percent were found to have atrial fibrillation according to the researchers.


FDA Approvals

Recent FDA Approvals

New Active Ingredient: Spravato TM (esketamine)
Nasal spray for the treatment of treatment-resistant depression(TRD) in combination with an oral antidepressant in adults [3/5/19 – Breakthrough Therapy; Fast Track; Priority Review – JANSSEN PHARMS]

New Combination Product: RocklatanTM (netarsudil/latanoprost)
Eye solution for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma [3/12/19 – AERIE PHARMS INC]

New Formulation Product: Tetracaine hydrochloride 0.5% Ophthalmic Solution
Eye solution for the short term and rapid treatment of eye pain caused by ophthalmic procedures [3/15/19 – BAUSCH HEALTH IRELAND LIMITED]


New Generics

New Generics Entering the Marketplace

*costs below based on a projected 30-day supply

Sensipar® (cinacalcet)
Indication: Secondary hyperparathyroidism (HPT)
Dosage Form/Strength: 30MG, 60MG, 90MG tablet
Average Wholesale Price (AWP): Generic = 30MG ($928) | 60MG ($1,856) | 90MG ($2,783) Brand = 30MG ($968) | 60MG ($1,936) | 90MG ($2,904)

Tekturna® (aliskiren)
Indication: High blood pressure
Dosage Form/Strength: 15MG, 30MG tablet
Average Wholesale Price (AWP): Generic = 15MG ($234) / 30MG ($296) | Brand = 15MG ($250) / 30MG ($325)