New And Noteworthy Approvals From 2018

The FDA is on track for another record setting year of new drug approvals.  Below we recap some significant approvals from the past year, spanning therapeutics, medical devices, and digital tools. | February 2018
Analysis of CT results and highlights cases that may have experienced a stroke

What you should know
Created a new regulatory classification for artificial intelligence driven platforms for clinical decision support.

Dexcom | March 2018
Integrated continuous glucose monitoring (iCGM) system

What you should know
First iCGM that can integrate with other compatible medical devices and electronic interfaces, including dosing systems, insulin pumps, and blood glucose meters.

IDx-DR | April 2018
Autonomous detection of diabetic retinopathy

What you should know
First AI-based diagnostic system that can provide a screening decision without clinician interpretation.

Hospira, a subsidiary of Pfizer | May 2018
Treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection

What you should know
First biosimilar to Epogen/Procrit.

Novartis | May 2018
Relapsed or refractory (r/r) large B-cell lymphoma

What you should know
New indication added following first approval for the CAR-T product in 2017.

Portola Pharmaceuticals | May 2018
Reversal of anticoagulation in patients treated with rivaroxaban or apixaban

What you should know
“Generation 1” approval for smaller batch product, available in only limited launch. Generation 2 product has YE2018 PDUFA data.

Amgen | May 2018
Preventive treatment of migraine in adults

What you should know

First approval of new class of migraine agents known as calcitonin gene-related peptide (CGRP) blockers.

Mylan | June 2018
Reduce the risk of infection during cancer treatment

What you should know
First biosimilar to Neulasta.

GW Pharmaceuticals | June 2018
Rare, severe forms of epilepsy

What you should know

First FDA-approved drug that contains a purified drug substance derived from marijuana.

Senseonics | June 2018
Implantable continuous glucose monitoring system

What you should know
First implantable product approved, capable of 90-day use.

Abbott | July 2018
Continuous glucose monitoring system

What you should know
Allows adult patients to make diabetes treatment decisions without obtaining a blood sample from the fingertip (fingerstick). Also has a companion app for smartphone use.

Alnylam | August 2018
Hereditary transthyretin-mediated amyloidosis in adult patients

What you should know
First RNA interference (RNAi) approval.

Apple | September 2018
Atrial fibrillation-detecting algorithm and ECG built into Apple Watch

What you should know
De Novo approval for incorporation of these features into a consumer-facing electronic device.

Merck | October 2018
HPV vaccine

What you should know
Extended the approved age range of the vaccine to include men and women ages 27 to 45.

Celltrion | November 2018
B-cell non-Hodgkin’s lymphoma (NHL)

What you should know
First biosimilar to Rituxan.

Loxo Oncology and Bayer | November 2018
Solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion

What you should know
Tissue agnostic approval – can be used in any tumor type with a specific gene fusion status.