• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » 2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them

2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them

December 17, 2014
CenterWatch Staff

Margaret A. Hamburg, M.D., commissioner of the FDA, spoke about 2014 drug approval data on the FDA’s official blog FDAVoice.

Based on preliminary data, 2014 was a strong year for novel drug approvals. The Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013. These numbers include both new molecular entities (NMEs), submitted to CDER in New Drug Applications (NDAs) and new therapeutic biologics submitted to CDER in Biologics License Applications (BLAs).

Hamburg said, “So far this year we’ve reached a milestone with a record 15 approvals for rare diseases. The previous high was 13 drugs in 2012. These results are all the more significant because patients with rare diseases often have few or no drugs available to treat their conditions.

“And here’s another point of interest—to date, 15 of the approvals have been first in their class drugs, another indicator of their potentially strong clinical impact,” Hamburg continued. “To ensure that 2014’s novel drugs get to patients as quickly as possible, CDER effectively employed a variety of regulatory tools including FDA’s expedited development and review programs—Fast Track, Priority Review, Accelerated Approval and our new Breakthrough Therapy designation.”

Early and repeated communications with sponsors also have been helpful in speeding products to market. One example is Blincyto, which was recently approved to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. CDER employed all of its expedited review programs to help get this drug to market as early as possible, five months ahead of its review goal date. The sponsor also benefited from incentives for drugs that treat rare diseases.

“One of the more challenging areas of drug development has been the rather barren field of antibacterial drugs,” said Hamburg. “Among our 2014 approvals to date are three new antibacterial drugs—Dalvance, Sivextro and Orbactiv—to treat skin infections, specifically acute bacterial skin and skin structure infections (ABSSSI). These drug approvals represent a welcome but modest increase in activity in this product area. Prior to 2014, only five new systemic antibacterial drugs were approved during the period from 2004 to 2013.

Hamburg also said, “Thirty-four of the 35 drugs approved so far in 2014 were approved before or on their Prescription Drug User Fee Act (PDUFA) review goal date and 23 of the 35 drugs were available to patients in the U.S. before they were available to patients in Europe.”

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing