NOVEL Health Strategies CHARTS: 2015 was a Record Year with the Highest NME/BLA Approvals Since 2006

Source: NOVEL Health Strategies Top Trends Report (Request a copy)

According to the FDA, in 2015 CDER approved 45 novel new drugs. 45 novel new drug approvals in CY 2015 is more than the average number approved annually during the past decade. From 2006 through 2014 CDER averaged about 28 novel new drug approvals per year.

16 of the 45 approved drugs were first in class

The following are the first in class drugs:

Addyi

Bridion

Corlanor

Cosentyx

Darzalex

Empliciti

Entresto

Ibrance

Kanuma

Nucala

Orkambi

Praluent

Praxbind

Strensiq

Unituxin

Xuriden

A recent article asked a question about access to new drugs for HCV. http://www.cnn.com/2016/01/27/opinions/miller-gilead-drug-price/index.html

It raises several questions such as:

While this is great news for the industry, the key question is whether these drugs are easily accessible by patients.

Do we need another government agency to ensure that all patients have access to much-needed drugs.