J&J wins FDA OK for their nasal spray ver­sion of a par­ty drug, now ap­proved for treat­ment-re­sis­tant ma­jor de­pres­sion

There it is. 

De­spite some se­ri­ous clin­i­cal fail­ures, the FDA has ap­proved J&J’s new drug es­ke­t­a­mine for ma­jor de­pres­sion, which will now hit the mar­ket as Spra­va­to.

An in­tranasal for­mu­la­tion of ke­t­a­mine, a horse tran­quil­iz­er that is bet­ter known in par­ty cir­cles as Spe­cial K, the drug won a warm as­sess­ment by FDA in­sid­ers as well as an over­whelm­ing vote in its fa­vor by a pan­el of out­side ex­perts or­ga­nized by the FDA.

The ex­perts and reg­u­la­tors were won over by the fact that most were aware of ke­t­a­mine’s years-long rep­u­ta­tion for deal­ing quick­ly with the most se­vere kinds of de­pres­sion. J&J tout­ed the da­ta that they had ac­quired in late-stage re­search, down­play­ing the fail­ures. But in de­pres­sion physi­cians are al­ready well used to deal­ing with hit-and-miss ther­a­peu­tic strate­gies, armed with a hap­haz­ard set of de­pres­sion drugs that of­ten don’t work.

This drug will be giv­en on­ly un­der care­ful su­per­vi­sion and a black box warn­ing re­gard­ing the risk of se­da­tion and dis­so­cia­tive be­hav­ior. It is one of J&J’s top late-stage pro­grams, tapped as a po­ten­tial block­buster.

“There has been a long-stand­ing need for ad­di­tion­al ef­fec­tive treat­ments for treat­ment-re­sis­tant de­pres­sion, a se­ri­ous and life-threat­en­ing con­di­tion,” said Tiffany Far­chione, the act­ing di­rec­tor of the Di­vi­sion of Psy­chi­a­try Prod­ucts in FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search. “Con­trolled clin­i­cal tri­als that stud­ied the safe­ty and ef­fi­ca­cy of this drug, along with care­ful re­view through the FDA’s drug ap­proval process in­clud­ing a ro­bust dis­cus­sion with our ex­ter­nal ad­vi­so­ry com­mit­tees, were im­por­tant to our de­ci­sion to ap­prove this treat­ment. Be­cause of safey con­cerns, the drug will on­ly be avail­able through a re­strict­ed dis­tri­b­u­tion sys­tem and it must be ad­min­is­tered in a cer­ti­fied med­ical of­fice where the health care provider can mon­i­tor the pa­tient.” 

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

UP­DAT­ED #ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Seat­tle Ge­net­ic­s' Astel­las-part­nered ADC nails con­fir­ma­to­ry PhI­II in urothe­lial can­cer

Nine months after Seattle Genetics nabbed an accelerated approval for its Astellas-partnered antibody-drug conjugate Padcev, the partners said the therapy has nailed a confirmatory Phase III, proving its worth in locally advanced or metastatic urothelial cancer.

Padcev, which has widely been tapped as a potential blockbuster, scored improvements in both overall survival and progression-free survival compared to chemotherapy, causing a 30% reduction in risk of death (p = 0.001) and 39% reduction in risk of disease progression or death (p<0.00001).

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.