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 July 13, 2022

7/12/2022

 
Regulatory Update

The FDA accepted the BLA for mosunetuzumab to treat relapsed or refractory follicular lymphoma in patients who have received at least two prior systemic therapies. A PDUFA date is set for 12/29/2022.

The FDA accepted the NDA for lecanemab to treat Alzheimer’s disease, and set a PDUFA date for 1/6/2023.

Two months after rejecting toripalimab due to a manufacturing quality process deficiency, the FDA accepted the resubmitted NDA and set a PDUFA date for 12/23/2022. An onsite inspection of the manufacturing plant will be required.

The FDA placed a hold on the Phase II/III ReMEDy2 trial (NCT05065216), due to the incidence of hypotension in patients treated with DM199.

Announced Research Updates

Nordic Nanovector discontinued the Phase IIb Paradigm trial, evaluating lutetium (177lu) lilotomab satetraxetan to treat refractory follicular lymphoma, after an interim analysis revealed low efficacy

Sarepta announced one-year functional results from 20 patients enrolled in cohort 1 of the open-label, Phase I, ENDEAVOR trial, where treatment with delandistrogene moxeparvovec improved the NSAA score compared to a historical control group of patients with DMD. There was one case of myocarditis identified in the Phase I ENDEAVOR trial, which appeared to resolve four months after treatment with IV methyl-prednisolone. Sarepta also announced four-year results from a four patient, Phase I/II trial, where delandistrogene moxeparvovec maintained a 7 point improvement in the North Star Ambulatory Assessment (NSAA) over baseline and a 9.4 point improvement compared to a historical control group in patients with Duchenne muscular dystrophy. 

Lysogene announced 24 month data from 16 patients enrolled in the 20 patient, Phase II/III, AAVance trial, where treatment with LYS-SAF302 resulted in a 22% decrease in heparan sulfate (HS) in the cerebrospinal fluid (CSF), a 20% decrease in HS-derived oligosaccharides in the CSF, 41% decrease in serum neurofilament light (NFL) levels and a 33% decrease in CSF NFL levels in patients with mucopolysaccharidosis Type IIIA (MPS IIIA).

MacroGenics discontinued a Phase 2 trial evaluating enoblituzumab in combination with retifanlimab or tebotelimab, in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck, after seven fatalities potentially associated with hemorrhagic events were reported.

Novo Nordisk announced that in the 32-week, 133 patient, Phase III, explorer7 trial, prophylaxis with concizumab resulted in an annual bleeding rate of 1.7 compared to 11.8 with no prophylaxis in patients with hemophilia A or B with inhibitors.

Sanofi announced that in the 13-month, 80 patient, Phase III, ATLAS-PPX trial, prophylaxis with fitusiran resulted in an annual bleeding rate of 0 compared to 61.1% with prior factor or bypassing agent prophylaxis in patients with hemophilia A or B with or without inhibitors.

Aldeyra announced that in a two-day, 50 patient, Phase II crossover trial, treatment with reproxalap decreased eye redness and increased tear production as measure with a Schirmer test in patients with dry eye disease.

Published Research Updates

In the 104-week, 206 patient, open-label, Phase II, BE ACTIVE 2 trial, a long-term extension of the BE ACTIVE trial, continued treatment with bimekizumab resulted in sustained improvement in pain, fatigue and function.

16-week results from the 52-week, 503 patient, Phase III, OASIS-1 trial, found that 69.3%of patients treated with mirikizumab achieved at least a 2-point improvement in their sPGA score and 64.3% achieved PASI90 compared to 6.5% and 6.5%with placebo in patients with moderate to severe plaque psoriasis. At 52-weeks, PASI90/PASI100/sPGA response was achieved with mirikizumab 250Q4W/placeboQ8W in 18.7%/9.9%/17.6%, mirikizumab 250Q4W/125Q8W in 85.6%/58.9%/85.6%, and mirikizumab 250Q4W/250Q8W in 84.6%/60.4%/82.4%. 

In a 90 patient cohort of an open-label, Phase I/Ib trial, treatment with mosunetuzumab resulted in a complete response (CR) rate of 60% compared to 14% in a historical control group that received copanlisib in patients with relapsed or refractory follicular lymphoma.

In the 94-patient, Phase II, open-label, POD1UM-202 trial, treatment with retifanlimab resulted in an objective response rate of 13.8% in patients with locally advanced or metastatic squamous cell carcinoma of the anal canal, who progressed on, or are intolerant of, platinum-based chemotherapy.

In a 33 patient, Phase II trial, treatment with eprenetapopt plus azacitidine resulted in relapse free survival of 12.5 months in post-transplant patients with TP53 mutant MDS and AML.

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.