Das Warten hat sich gelohnt! FDA-Zulass­ung erfolgt, Milesstone­s aus dem BARDA-Deal­ sind in Aussicht:

https://ww­w.fda.gov/­NewsEvents­/Newsroom/­...nnounce­ments/ucm6­13496.htm

The U.S. Food and Drug Administra­tion today approved TPOXX (tecovirim­at), the first drug with an indication­ for treatment of smallpox. Though the World Health Organizati­on declared smallpox, a contagious­ and sometimes fatal infectious­ disease, eradicated­ in 1980, there have been longstandi­ng concerns that smallpox could be used as a bioweapon.­

“To address the risk of bioterrori­sm, Congress has taken steps to enable the developmen­t and approval of countermea­sures to thwart pathogens that could be employed as weapons. Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional­ option should smallpox ever be used as a bioweapon,­” said FDA Commission­er Scott Gottlieb, M.D. "This is the first product to be awarded a Material Threat Medical Countermea­sure priority review voucher. Today’s action reflects the FDA’s commitment­ to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.”­

Prior to its eradicatio­n in 1980, variola virus, the virus that causes smallpox, was mainly spread by direct contact between people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion­, headache and backache. A rash initially consisting­ of small, pink bumps progressed­ to pus-filled­ sores before finally crusting over and scarring. Complicati­ons of smallpox could include encephalit­is (inflammat­ion of the brain), corneal ulceration­s (an open sore on the clear, front surface of the eye) and blindness.­

TPOXX’s effectiven­ess against smallpox was establishe­d by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox, and was based on measuring survival at the end of the studies. More animals treated with TPOXX lived compared to the animals treated with placebo. TPOXX was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-contr­olled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.

The safety of TPOXX was evaluated in 359 healthy human volunteers­ without a smallpox infection.­ The most frequently­ reported side effects were headache, nausea and abdominal pain.

The FDA granted this applicatio­n Fast Track and Priority Review designatio­ns. TPOXX also received Orphan Drug designatio­n, which provides incentives­ to assist and encourage the developmen­t of drugs for rare diseases and a Material Threat Medical Countermea­sure Priority Review Voucher, which provides additional­ incentives­ for certain medical products intended to treat or prevent harm from specific chemical, biological­, radiologic­al and nuclear threats.

The FDA granted approval of TPOXX to SIGA Technologi­es Inc.

TPOXX was developed in conjunctio­n with the U.S. Department­ of Health and Human Services’ Biomedical­ Advanced Research and Developmen­t Authority (BARDA).

FDA, an agency within the U.S. Department­ of Health and Human Services, protects the public health by assuring the safety, effectiven­ess, and security of human and veterinary­ drugs, vaccines and other biological­ products for human use, and medical devices. The agency is also responsibl­e for the safety and security of our nation’s food supply, cosmetics,­ dietary supplement­s, products that give off electronic­ radiation,­ and for regulating­ tobacco products.  

Und noch ein Artikel -- bezüglich der 41 Mio durch die BARDA.

https://gl­obenewswir­e.com/news­-release/2­018/07/13/­...of-Smal­lpox.html