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.


Zachary Brennan

managing editor, RAPS

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.