FDA OKs first cannabi­noid, gives green light to GW Phar­ma’s Epid­i­olex for rare seizures

GW Phar­ma $GW­PH fin­ished its layup at the FDA to­day with Epid­i­olex, grab­bing its first ever mar­ket­ing OK for one of its cannabi­noid drugs and set­ting up the biotech for a ma­jor shift to­ward com­mer­cial­iza­tion.

Justin Grover, GW Phar­ma CEO

Two months af­ter a unan­i­mous rec­om­men­da­tion by an out­side group of FDA ex­perts and some glow­ing rec­om­men­da­tions in the in­ter­nal re­view, GW will now set out to open up a new class of meds af­ter demon­strat­ing the drug’s abil­i­ty to pre­vent seizures in chil­dren suf­fer­ing from rare cas­es of Lennox-Gas­taut syn­drome and Dravet syn­drome. 

The ap­proval was record­ed on the FDA’s web­site and word spread quick­ly through Twit­ter.

Clar­i­vate has pegged 2022 sales at a block­buster sized $1.2 bil­lion, mak­ing this roll­out a huge­ly im­por­tant event for the UK-based com­pa­ny.

The FDA’s Scott Got­tlieb did the hon­ors in the state­ment to­day, cel­e­brat­ing GW for the work they did, and warn­ing any­one else against try­ing to mar­ket cannabis-re­lat­ed prod­ucts with du­bi­ous sup­port for their claims.

Scott Got­tlieb

“This ap­proval serves as a re­minder that ad­vanc­ing sound de­vel­op­ment pro­grams that prop­er­ly eval­u­ate ac­tive in­gre­di­ents con­tained in mar­i­jua­na can lead to im­por­tant med­ical ther­a­pies. And, the FDA is com­mit­ted to this kind of care­ful sci­en­tif­ic re­search and drug de­vel­op­ment,” said Got­tlieb. “Con­trolled clin­i­cal tri­als test­ing the safe­ty and ef­fi­ca­cy of a drug, along with care­ful re­view through the FDA’s drug ap­proval process, is the most ap­pro­pri­ate way to bring mar­i­jua­na-de­rived treat­ments to pa­tients. Be­cause of the ad­e­quate and well-con­trolled clin­i­cal stud­ies that sup­port­ed this ap­proval, pre­scribers can have con­fi­dence in the drug’s uni­form strength and con­sis­tent de­liv­ery that sup­port ap­pro­pri­ate dos­ing need­ed for treat­ing pa­tients with these com­plex and se­ri­ous epilep­sy syn­dromes. We’ll con­tin­ue to sup­port rig­or­ous sci­en­tif­ic re­search on the po­ten­tial med­ical us­es of mar­i­jua­na-de­rived prod­ucts and work with prod­uct de­vel­op­ers who are in­ter­est­ed in bring­ing pa­tients safe and ef­fec­tive, high qual­i­ty prod­ucts. But, at the same time, we are pre­pared to take ac­tion when we see the il­le­gal mar­ket­ing of CBD-con­tain­ing prod­ucts with se­ri­ous, un­proven med­ical claims. Mar­ket­ing un­ap­proved prod­ucts, with un­cer­tain dosages and for­mu­la­tions can keep pa­tients from ac­cess­ing ap­pro­pri­ate, rec­og­nized ther­a­pies to treat se­ri­ous and even fa­tal dis­eases.”

GW CEO Justin Gov­er told the Fi­nan­cial Times over the week­end that it had tak­en “an aw­ful long time to get to where we are . . . but we’ve re­al­ly built a huge lead. We’re the world-lead­ers in cannabi­noid sci­ence, and I think we ex­pect to stay there for quite some time.”

From GW’s per­spec­tive this is just the be­gin­ning, with plans to pur­sue more re­search work in a va­ri­ety of ail­ments.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.