Heat intolerance

Food And Drug Administration Grants Two New Label Changes To Tirosint®-Sol (Levothyroxine Sodium) Oral Solution

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Monday, December 4, 2023
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The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hypothyroidism.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hypothyroidism.
  • The first regards the use of Tirosint-SOL in the presence of proton pump inhibitor (PPI) therapy.
  • Both label changes help to differentiate Tirosint-SOL from other levothyroxine therapies.
  • Similarly, current labeling for all levothyroxine sodium therapies instructs patients to self-administer the drug once daily, on an empty stomach, one-half to one hour before breakfast.

Professional Golfer Aza Muñoz Returns to LPGA Tour with New Solution for Treating Her Hypothyroidism

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Wednesday, August 24, 2022
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Professional golfer Azahara (Aza) Muoz will return to the LPGA Tour this fall as a new mom and as the new spokesperson for Tirosint-SOL (levothyroxine sodium) solution .

Key Points: 
  • Professional golfer Azahara (Aza) Muoz will return to the LPGA Tour this fall as a new mom and as the new spokesperson for Tirosint-SOL (levothyroxine sodium) solution .
  • My body ached, and practicing golf was so tough because I was always tired, said Muoz.
  • She tried to treat her condition using conventional thyroid medicine, but she still struggled with the symptoms of hypothyroidism.
  • We wish Aza the best of luck and health as she returns to the Tour!

Sangamo Therapeutics Announces Updated Preliminary Phase 1/2 Data Showing Tolerability and Sustained Elevated α-Gal A Enzyme Activity in Patients With Fabry Disease

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Monday, February 7, 2022
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For the two ERT pseudo-nave patients, -Gal A activity was 3-fold above mean normal at week 52 (Cohort 1) and 4-fold above mean normal at week 40 (Cohort 2).

Key Points: 
  • For the two ERT pseudo-nave patients, -Gal A activity was 3-fold above mean normal at week 52 (Cohort 1) and 4-fold above mean normal at week 40 (Cohort 2).
  • The two patients in the first dose cohort have now begun the long-term follow-up study.
  • For the first patient in the third dose cohort (3e13 vg/kg), -Gal A activity has increased into mean normal range at week 2.
  • As of the cutoff date, isaralgagene civaparvovec was generally well tolerated across three dose cohorts in the five treated patients.

Sangamo Therapeutics Announces Preliminary Phase 1/2 Data Showing Tolerability and Sustained Elevated α-Gal A Enzyme Activity in Patients With Fabry Disease

Retrieved on: 
Thursday, November 4, 2021
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Activity of 2-fold to 15-fold above mean normal was observed at last measurement as of the cutoff date.

Key Points: 
  • Activity of 2-fold to 15-fold above mean normal was observed at last measurement as of the cutoff date.
  • A presentation containing additional details about the study and these results is available on the Events & Presentations page of Sangamos website.
  • Sangamo expects to provide updated results from the STAAR study throughout 2022 and present these results at a medical meeting.
  • Based on STAAR study results to date, Sangamo has initiated planning for a Phase 3 clinical trial.