Regulatory channel feed

DBV lays off em­ploy­ees, scales down pro­grams af­ter re­ceiv­ing no word from FDA

For years, it was a two-company race to develop the first treatment for peanut allergy. Then in January, Aimmune won approval for its peanut powder pill and now it looks like their competitor and the erstwhile frontrunner is struggling to stay alive.

DBV Technologies said today that it has not heard from the FDA since the agency said they were concerned about how effective DBV’s experimental peanut patch would be and, as a result, plan to lay off a “significant” number of employees. These cuts will be part of a “global and comprehensive restructuring plan” that will begin immediately and attempt to keep the company solvent past Q1 2021.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis yanks ap­pli­ca­tion from the EMA af­ter reg­u­la­tors say re­searchers nev­er proved ef­fi­ca­cy of their $3.4B dry eye drug

Novartis is throwing in the towel on its campaign to get their dry eye disease drug Xiidra (lifitegrast) approved in Europe after regulators concluded that the drug fell short of the continental gold standard on drug approvals.

The EMA put out word that the Basel-based Novartis never proved the drug was actually effective at treating dry eye disease and that researchers had avoided using the standard approach — artificial tears — “in an optimal way.” The EMA concluded the drug didn’t pass the efficacy/safety standard in place, though the FDA green-lighted the drug 4 years ago. And Novartis concluded that there was no timely way to satisfy their concerns about a drug now sold in the US for a list price of around $6,600 a year.

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Af­ter 2 de­lays, Zo­genix nabs FDA ap­proval for epilep­sy drug, sets price at 3X its GW Phar­ma com­peti­tor

Fourteen months after refusing to file Zogenix’s first application, the FDA has approved the California biotech’s lead drug for a rare form of epilepsy called Dravet syndrome. It will be branded as Fintepla.

The company said Friday they will charge on average $96,000 for the drug — or about 3 times what GW Pharma, their main competitor, charges for their Dravet syndrome drug.

Investors have been anticipating a competition between Zogenix and GW Pharma for years. In 2018, GW won a landmark FDA approval for the first cannabinoid drug. Called Epidiolex, it had been shown in late-stage trials to reduce seizures by around 40% and represented the first approved drug for the 15,000 to 20,000 Americans with Dravet syndrome, each of whom can experience dozens of seizure per month.

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Ab­b­Vie’s first post-merg­er Al­ler­gan drug pitch strikes out with the FDA as reg­u­la­tors turn thumbs down on Lu­cen­tis chal­lenger

Allergan has received its first FDA decision since officially becoming a part of AbbVie. And it’s bad news.

Regulators have spurned abicipar, the neovascular age-related macular degeneration (wet AMD) drug that Allergan chief Brent Saunders had touted as one of four “expected” approvals just before announcing the $63 billion sale.

The company said the complete response letter took issue with “the rate of intraocular inflammation” observed after administration of the anti-VEGF injection (2mg/0.05 mL) — which translates to an unfavorable benefit-risk ratio.

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FDA OKs Mer­ck’s heavy­weight Keytru­da for can­cer niche — trig­ger­ing ti­tle fight with the street brawlers at Re­gen­eron

When Regeneron won its first OK for their PD-1 Libtayo as a treatment for recurrent or metastatic cutaneous squamous cell carcinoma, the second most common form of skin cancer, company president George Yancopoulos crowed about their ability to grab a major niche market left wide open by the 2 big powerhouses in the field, Merck and Bristol Myers.

Today, though, Regeneron and their partners at Sanofi no longer enjoy a monopoly in that particular field. Merck grabbed an OK for their top-selling PD-1 Keytruda in the same group of patients. But don’t expect Regeneron — still struggling to boost sales — to let go of their best-in-class claims.

FDA lifts par­tial hold on can­cer drug af­ter In­nate re­solves man­u­fac­tur­ing is­sue

Innate Pharma has smoothed over a bump on a Phase II for lacutamab, resuming enrollment in the US as the FDA lifts its partial hold.

The hold, which was issued in January, came after the French biotech stopped treating new patients following discussions with regulators in Europe. Its manufacturing subcontractor, Rentschler Fill Solutions, had abruptly filed for bankruptcy and withdrawn a certificate of conformity on the lacutamab batches they produced.

Stephen Hahn (AP Images)

Hahn tes­ti­fies on Covid-19 re­sponse, says FDA on tar­get to hit user fee goals

FDA commissioner Stephen Hahn on Tuesday testified before the House Energy and Commerce Committee on his agency’s response to the coronavirus disease (Covid-19) pandemic.

User fee goals, policy review

Despite an “incredible surge in volume” of applications and constraints on the agency’s ability to conduct inspections, Hahn said that the FDA “has maintained the same pace of meeting its goals on applications for medical products for the last six months that is has maintained in recent years.”

Lynn Seely, Myovant CEO (Myovant)

My­ovant read­ies NDA #3 as re­l­u­golix sails to its 5th pos­i­tive PhI­II — this time in en­dometrio­sis

Myovant $MYOV is on a roll.

In the last few days the biotech spawned on Vivek Ramaswamy’s Roivant platform has posted a positive readout on prostate cancer for their drug relugolix, followed by a priority review reward from the FDA. It’s got another NDA on uterine fibroids lined up. And now it has posted its second round of promising pivotal results for endometriosis, setting the stage for NDA number 3.

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Stephen Hahn, FDA commissioner (Alex Brandon/AP Images)

Law­mak­ers ask FDA to out­line Covid-19 vac­cine ap­proval process

Key Democratic members in the US House of Representatives have called on FDA commissioner Stephen Hahn to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.

In a letter dated June 18, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairman of the committee’s Subcommittee on Economic and Consumer Policy, along with Rep. James Clyburn (D-SC), chairman of the Select Subcommittee on the Coronavirus Crisis, offered suggestions as to how Hahn could improve public confidence in any Covid-19 vaccines his agency might authorize. They also invited the commissioner to brief their staff on the topic on July 2.

David Gonyer, Evoke CEO (Evoke Pharma)

Evoke Phar­ma fi­nal­ly lands ap­proval for lead and on­ly drug

Over a year after the FDA first rebuffed Evoke’s application, the agency has approved the small biotech’s lone drug, a treatment for a common gastrointestinal complication of diabetes.

The drug, known as Gimoti, is a nasal spray for treating diabetic gastroparesis, a disorder in which the muscles in the stomach can’t properly clear food. In a Phase III study in 2016, the drug actually missed its primary endpoint but showed a “clinically meaningful benefit” in 51% of patients with moderate to severe symptoms at the outset.