Revance Therapeutics Says FDA Approves DAXXIFY For Injection To Treat Cervical Dystonia In Adults

RTTNews | il y a 720
Revance Therapeutics Says FDA Approves DAXXIFY For Injection To Treat Cervical Dystonia In Adults

(RTTNews) - Revance Therapeutics, Inc. (RVNC) announced Monday that the U.S. Food and Drug Administration (FDA) has approved the first therapeutic indication for DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults.

The U.S. approval of DAXXIFY for the treatment of cervical dystonia in adults was based on data generated in the Phase 3 clinical program (ASPEN 1, ASPEN OLS), which included 382 patients and 1,240 treatments across up to five injection cycles over an 88-week time span, based on the masked, randomized ASPEN-1 and ASPEN Open Label Study (OLS).2-5 In the pivotal ASPEN clinical study,

Based on the ASPEN OLS study, symptoms continued to improve with successive DAXXIFY treatments at doses up to 300U, while adverse events remained low.

In 2017, the U.S. FDA granted orphan drug designation to DAXXIFY for the treatment of cervical dystonia in adults.

DAXXIFY, powered by Peptide Exchange Technology, was previously approved by the FDA for the temporary improvement of glabellar lines (frown lines) in adults in September 2022 and is the first true innovation in neuromodulator product formulation in more than 30 years.

Cervical dystonia is a chronic, debilitating disease in which the neck muscles contract involuntarily, causing abnormal movements, pain and awkward posture of the head and neck. Neuromodulators are considered the first line of treatment for this condition.

For More Such Health News, visit rttnews.com

read more
U.S. Construction Spending Unexpectedly Sees Further Downside In June

U.S. Construction Spending Unexpectedly Sees Further Downside In June

The Commerce Department released a report on Friday unexpectedly showing a continued decrease by U.S. construction spending in the month of June. The report said construction spending fell by 0.4 percent to an annual rate of $2.136 trillion in June after sliding by 0.5 percent to a revised rate of $2.144 trillion in May.
RTTNews | il y a 2
U.S. Consumer Sentiment Improves Marginally Less Than Previously Estimated In July

U.S. Consumer Sentiment Improves Marginally Less Than Previously Estimated In July

Revised data released by the University of Michigan on Friday showed consumer sentiment in the U.S. improved marginally less than previously estimated in the month of July. The University of Michigan said its consumer sentiment index for July was downwardly revised to 61.7 from a preliminary reading of 61.8. Economists had expected the index to be upwardly revised to 62.0.
RTTNews | il y a 2
U.S. Manufacturing Index Unexpectedly Dips To Nine-Month Low In July

U.S. Manufacturing Index Unexpectedly Dips To Nine-Month Low In July

Manufacturing activity in the U.S. unexpectedly contracted at a slightly faster rate in the month of July, according to a report released by the Institute for Supply Management on Friday. The ISM said its manufacturing PMI edged down to 48.0 in July after inching up to 49.0 in June with a reading below 50 indicating contraction.
RTTNews | il y a 2
Eurozone Inflation Steady At 2% ECB Target

Eurozone Inflation Steady At 2% ECB Target

Euro area consumer price inflation was unchanged at the European Central Bank's 2 percent target in July, easing the pressure for more easing. The harmonized index of consumer prices increased 2.0 percent year-on-year in July, the same rate of increase as seen in June. Inflation was forecast to ease marginally to 1.9 percent.
RTTNews | il y a 2