EMA, FDA and WHO prep for new coro­n­avirus treat­ments, IVDs

Fol­low­ing the World Health Or­ga­ni­za­tion’s (WHO) de­ter­mi­na­tion last week that the spread of the nov­el coro­n­avirus (2019-nCoV) from Wuhan, Chi­na is a pub­lic health emer­gency of in­ter­na­tion­al con­cern, the Eu­ro­pean Med­i­cines Agency (EMA), FDA and WHO have tak­en var­i­ous pre­cau­tions and pre­pared for new med­i­cines, vac­cines and in vit­ro di­ag­nos­tics (IVDs).

FDA on Tues­day is­sued an Emer­gency Use Au­tho­riza­tion (EUA) to au­tho­rize the emer­gency use of Cen­ters for Dis­ease Con­trol and Pre­ven­tion’s (CDC) 2019-Nov­el Coro­n­avirus (2019-nCoV) Re­al-Time Re­verse Tran­scrip­tase (RT)-PCR Di­ag­nos­tic Pan­el for the “pre­sump­tive qual­i­ta­tive de­tec­tion of nu­cle­ic acid from the 2019-nCoV in up­per and low­er res­pi­ra­to­ry spec­i­mens (such as na­sopha­ryn­geal or oropha­ryn­geal swabs, spu­tum, low­er res­pi­ra­to­ry tract as­pi­rates, bron­choalve­o­lar lavage, and na­sopha­ryn­geal wash/as­pi­rate or nasal as­pi­rate) col­lect­ed from in­di­vid­u­als who meet CDC cri­te­ria for 2019-nCoV test­ing.”

To date, this test has been lim­it­ed to use at CDC lab­o­ra­to­ries, but FDA said to­day’s au­tho­riza­tion al­lows the use of the test at any CDC-qual­i­fied lab na­tion­wide.

EMA al­so said Tues­day that it is ready to sup­port drug de­vel­op­ers with all avail­able reg­u­la­to­ry tools (i.e., sci­en­tif­ic ad­vice, the PRIME scheme, the ac­cel­er­at­ed as­sess­ment and con­di­tion­al mar­ket­ing au­tho­riza­tion) to ad­vance and ex­pe­dite the de­vel­op­ment of ways to fight and pre­vent the spread of this virus.

“De­vel­op­ers work­ing on med­i­c­i­nal prod­ucts or vac­cines that could be used for treat­ment or pre­ven­tion of nov­el coro­n­avirus 2019-nCoV in­fec­tions are en­cour­aged to con­tact the Agency and dis­cuss their strat­e­gy for ev­i­dence gen­er­a­tion as soon as pos­si­ble. They can con­tact EMA by send­ing an email to 2019-nCoV@ema.eu­ropa.eu for ini­tial dis­cus­sions with EU reg­u­la­tors,” EMA said.

WHO on Tues­day said that there are now more than 20,000 cas­es of 2019-nCoV and 425 deaths. The death toll rose to 490 by Tues­day evening, ac­cord­ing to the Chi­nese gov­ern­ment.

Al­most a dozen clin­i­cal tri­als are be­gin­ning to take shape in Chi­na, in­clud­ing one for a re­com­bi­nase aid­ed am­pli­fi­ca­tion (RAA) as­say at a Bei­jing hos­pi­tal, as well as one to test the ef­fi­ca­cy and safe­ty of the an­tivi­ral treat­ment ar­bidol in pa­tients with 2019-nCoV.

The US De­part­ment of Health and Hu­man Ser­vices (HHS), af­ter de­clar­ing a pub­lic health emer­gency last Fri­day, said Tues­day that it’s work­ing with Re­gen­eron Phar­ma­ceu­ti­cals to de­vel­op mul­ti­ple mon­o­clon­al an­ti­bod­ies that could be used to treat 2019-nCoV. Oth­er large bio­phar­ma com­pa­nies are al­so work­ing on treat­ments and vac­cines, in­clud­ing Gilead Sci­ences, Glax­o­SmithK­line and John­son & John­son.

And the US Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA) is pro­vid­ing a por­tal for com­pa­nies and in­ter­est­ed stake­hold­ers to sub­mit mar­ket re­search pack­ages. FDA last week al­so out­lined the prod­uct de­vel­op­ment process for com­bat­ing this virus.

“Fed­er­al agen­cies are par­tic­u­lar­ly in­ter­est­ed in iden­ti­fy­ing prod­ucts and tech­nolo­gies that have pro­gressed in­to or be­yond non-clin­i­cal stud­ies, have es­tab­lished large-scale com­mer­cial Good Man­u­fac­tur­ing Prac­tices (cGMP) man­u­fac­tur­ing ca­pa­bil­i­ty, or uti­lize a plat­form al­ready ap­proved by the U.S. Food and Drug Ad­min­is­tra­tion (FDA),” HHS said.

Mean­while, FDA, which has can­celed all staff trav­el to Chi­na, on Tues­day said it is aware that some blood es­tab­lish­ments are con­sid­er­ing donor ed­u­ca­tion and/or donor de­fer­ral mea­sures in re­sponse to 2019-nCoV. How­ev­er, FDA said that res­pi­ra­to­ry virus­es, in gen­er­al, are not known to be trans­mit­ted by blood trans­fu­sion and there have not been any re­port­ed cas­es of trans­fu­sion-trans­mit­ted coro­n­avirus.

“Rou­tine blood donor screen­ing mea­sures that are al­ready in place should pre­vent in­di­vid­u­als with clin­i­cal res­pi­ra­to­ry in­fec­tions from do­nat­ing blood,” FDA says.

WHO al­so pub­lished its Emer­gency Use List­ing (EUL) pro­ce­dure to stream­line the process by which new or un­li­censed prod­ucts can be used dur­ing pub­lic health emer­gen­cies. The EUL re­places the Emer­gency Use As­sess­ment and List­ing (EU­AL) pro­ce­dure, which was used dur­ing the West Africa Ebo­la out­break of 2014-2016.

Ed­i­tor’s note: Ar­ti­cle up­date on 2/4/20 with more in­for­ma­tion about the EUA and the death toll in Chi­na.


RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

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