Prescribe Right
Prescribe Right
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • Contact Us
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • Contact Us
Pipeline News and Updates
Picture

Update for June 1, 2022

6/1/2022

 
Regulatory Update
 
The FDA approved tapinarof 1% cream (Vtama, Dermavant Sciences), on 5/24/2022, for the treatment of plaque psoriasis.
 
The FDA accepted the BLA for etranacogene dezaparvoveca, a one-time treatment for hemophilia B, with a potential PDUFA date of 11/24/2022. 
 
The FDA accepted the BLA for mirvetuximab soravtansine to treat folate receptor alpha-high, platinum-resistant ovarian cancer and set a PDUFA date for 11/28/2022.
 
The FDA accepted the NDA for omaveloxolone for the treatment of Friedreich’s ataxia and set a PDUFA date for 11/30/2022.
 
The FDA requested additional, unspecified information for valoctocogene roxaparvovec, so BioMarin is delaying submission of an NDA until the end of September 2022.
 
The FDA extended the PDUFA date for ublituximab, to 12/28/2022, to allow time to review new data requested by the FDA.
 
Announced Research Updates
 
Concert announced that in a 24-week,706 patients, Phase III, THRIVE-AA1 trial, treatment with CTP-543 resulted in achievement of a SALT score of 20 or less in 41.5% of patients treated with 12 mg and 29.6% who received 8 mg compared to 0.8% with placebo in patients with moderate to severe alopecia areata. 
 
Lilly announced that in the 40-week, 544 patient, Phase III, LUCENT-2 trial, patients who achieved remission in the LUCENT-1 induction trial were re-randomized to mirikizumab or placebo. 49.9% of patients treated with mirikizumab achieved or maintained remission compared to 25.1% with placebo
 
Pfizer announced that in the 52-week, 433 patient, Phase III, ELEVATE UC 52 trial, 32.1% of patients treated with etrasimod achieved remission compared to 6.7% with placebo in patients with moderately-to-severely active ulcerative colitis.
 
Elevar announced that in an 80 patient, Phase II trial, treatment with apatinib resulted in an ORR of 15.1% in patients with progressive recurrent or metastatic adenoid cystic carcinoma.
 
SpringWorks announced that in a 142 patient, Phase II trial, treatment with nirogacestat reduced PFS by 41% compared to placebo in patients with desmoid tumors.
 
Published Research Updates
 
In the 12-week, 1,162 patient, Phase III, LUCENT-1 trial, 24.2% of patients treated with mirikizumab achieved remission compared to 13.3% with placebo in patients with moderate-to-severe active ulcerative colitis. 
 
The Phase III, BRIGHTER trial was discontinued after 714 patients when an interim analysis found no improvement in the overall survival from adding napabucasin to nab-paclitaxel and gemcitabine compared to the two drugs alone in the treatment of metastatic pancreatic ductal adenocarcinoma.


Comments are closed.
    Stay informed, subscribe to the 
    ​
    Prescribe Right Pharmaceutical Pipeline Tracker
    Latest Tweets from Prescribe Right

    Archives

    March 2023
    February 2023
    January 2023
    December 2022
    October 2022
    September 2022
    August 2022
    July 2022
    June 2022
    May 2022
    April 2022
    March 2022
    February 2022
    January 2022
    December 2021
    November 2021
    October 2021
    September 2021
    August 2021
    July 2021
    June 2021
    May 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    February 2020
    January 2020
    December 2019
    November 2019
    October 2019
    September 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    June 2018
    May 2018
    April 2018
    March 2018
    February 2018
    January 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    August 2015

    RSS Feed

Services

Pharmaceutical Pipeline Tracker​
Consulting

Company

About
Blog
Tweets

Support

Contact
© COPYRIGHT 2015. ALL RIGHTS RESERVED.