Roche’s Actem­ra — and the IL-6 drug class by ex­ten­sion — may have a role in the fight against Covid-19 af­ter all.

Da­ta from a new Phase III study showed that adding the drug to stan­dard of care could re­duce hos­pi­tal­ized pa­tients’ like­li­hood of need­ing mech­a­nism ven­ti­la­tion, the Swiss phar­ma gi­ant re­port­ed. Im­por­tant­ly, the ma­jor­i­ty of the 389 en­rolled pa­tients are from mi­nor­i­ty racial and eth­nic groups who are of­ten un­der­rep­re­sent­ed in clin­i­cal tri­als but bear the brunt of the pan­dem­ic.

On the pri­ma­ry end­point, pa­tients with Covid-as­so­ci­at­ed pneu­mo­nia who took Actem­ra were 44% less like­ly to need mech­a­nism ven­ti­la­tion or die down the road, com­pared to the place­bo arm (p-val­ue = 0.0348). The pro­por­tions of pa­tients who did with­in 28 days were 12.2% and 19.3%, re­spec­tive­ly.

Dubbed EM­PACTA, the tri­al used a dif­fer­ent out­come mea­sure from that used in the CO­V­AC­TA study, which al­so in­volved pa­tients with pneu­mo­nia but ap­peared to have re­cruit­ed a more se­vere group, and fo­cused on im­prove­ment in clin­i­cal sta­tus. Actem­ra failed to dif­fer­en­ti­ate it­self from place­bo there, spelling what many as­sumed was an end to the idea of re­pur­pos­ing the rheuma­toid arthri­tis drug to fight the un­con­trolled im­mune re­sponse and lung dam­age that can re­sult from Covid-19.

Levi Gar­raway

Back in Ju­ly, Roche in­ves­ti­ga­tors did high­light one bright spot — a mod­est 0.037 p val­ue for cut­ting the time to dis­charge — which didn’t count for much with the pri­ma­ry end­point flop.

But that da­ta point wasn’t held up in the new num­bers re­leased this morn­ing, as the dif­fer­ence in time to hos­pi­tal dis­charge or “ready for dis­charge” at day 28 was not sta­tis­ti­cal­ly sig­nif­i­cant. Me­di­an days to dis­charge were 6 for Actem­ra and 7.5 for place­bo, with a p-val­ue of 0.2456.

All the oth­er sec­ondary end­points al­so failed to hit sta­tis­ti­cal sig­nif­i­cance, in­clud­ing mor­tal­i­ty and time to clin­i­cal fail­ure.

It’s un­clear how these re­sults would stack up in the eyes of reg­u­la­tors as Roche brings the da­ta to the FDA and oth­er agen­cies around the world. Levi Gar­raway, head of glob­al prod­uct de­vel­op­ment, said that re­duc­ing the need for mech­a­nism ven­ti­la­tion is “an im­por­tant out­come.”

In sep­a­rate stud­ies, Re­gen­eron and Sanofi have con­clud­ed ear­ly on that Kevzara — which works sim­i­lar­ly to Actem­ra, block­ing the cy­tokine IL-6 — was like­ly hav­ing lit­tle ef­fect on most but the most crit­i­cal pa­tients (who are al­ready on ven­ti­la­tors at en­roll­ment). The drug lat­er failed all pri­ma­ry and sec­ondary end­points even in that sub­group, and the part­ners an­nounced they were es­sen­tial­ly pulling a plug on the pro­gram.

Roche is ap­par­ent­ly not ready to give in. There’s one more Phase III study un­der­way test­ing a com­bi­na­tion of Actem­ra and remde­sivir, Gilead’s EUA-blessed an­tivi­ral. Clin­i­cal sta­tus will be the pri­ma­ry end­point for the REM­DAC­TA tri­al, which tar­gets se­vere pa­tients with pneu­mo­nia; sec­ondary end­points in­clude me­chan­i­cal ven­ti­la­tion, mor­tal­i­ty and in­ten­sive care vari­ables.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

While both Pfizer/BioNTech and Moderna are looking to administer boosters for their Covid-19 vaccines six months after the initial two-dose series, J&J — which has vaccinated about 15 million Americans so far with its one-shot vaccine — is taking a more unique approach with boosters.

According to briefing documents released ahead of Friday’s FDA adcomm on the booster dose, J&J is calling for its boosters to be administered anywhere from two months to six months following the initial shot, depending on the strength of the immune responses.

The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries.

Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.