EU review extended for marketing authorisation application for haemophilia A gene therapy Valrox (valoctocogene roxaparvove)

PharmaTimes
The company disclosed in a US Securities and Exchange Commission filing that European Medicines Agency has asked for full 52-week results from 134 patients taking part in ongoing phase III study and potential submission of data is anticiparted by end of first quarter of 2021.

Treatment of distal deep vein thrombosis

Cochrane Database of Systematic Reviews
Review of 8 RCTs (n=1,239) found evidence of benefit for anticoagulation therapy using vitamin K antagonists with little or no difference in major bleeding events although there was an increase in clinically relevant non‐major bleeding vs no intervention or placebo.

Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury

Journal of the American Medical Association
RCT (n=1,063) found that, among patients with moderate to severe traumatic brain injury, out-of-hospital tranexamic acid administration within 2 hours of injury vs placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale.

Andexanet alfa (Ondexxya®) accepted for use within NHS Scotland on interim basis subject to ongoing evaluation and future reassessment

Scottish Medicines Consortium
Andexanet alfa intravenous infusion is approved for adult patients treated with a direct factor Xa inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Low molecular weight heparin for prevention of microvascular occlusion in digital replantation

Cochrane Database of Systematic Reviews
In this updated review (4 RCTs, n=258) low to very low‐certainty evidence showed no benefit from low molecular weight compared to unfractionated heparin on success rates of replantation or affect microvascular insufficiency due to vessel occlusion.

Andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban – second appraisal consultation

National Institute for Health and Care Excellence
In DRAFT guidance, NICE recommends andexanet alfa as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding, only if the bleed is in the GI tract and it is provided according to the commercial arrangement.

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services