Search Results for “FDA” – Page 46 – media

FDA rejection sets back Regeneron’s plan to defend top-selling eye drug

Dive Brief: Regeneron Pharmaceuticals is facing a delay for a much-anticipated new version of its best-selling eye medicine after failing to win U.S. approval on Tuesday because of a manufacturing issue. The Food and Drug Administration issued a complete response letter for the high-dose version of Eylea, citing inspection findings at a third-party facility that fills vials of the medication. Regeneron said it’s working with the FDA and the third party to resolve the issues “as quickly as possible.” Importantly, the FDA did not cite any issues with the drug’s safety or efficacy and isn’t asking for new clinical trials. The agency also did not find any issues with the labeling or manufacturing of the actual drug substance, Regeneron said. Dive Insight: While the issue sounds relatively minor, any delay is significant for Regeneron, and the company’s shares tumbled around 11% during trading sessions on Tuesday and Wednesday. Eylea is ...
- Source: drugdu
- 105
- June 30, 2023
AbbVie, Genmab’s Epkinly shows promise in follicular lymphoma. Will FDA get on board?

Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear. Epkinly significantly beat back tumors in 82% of patients with relapsed or refractory follicular lymphoma in a phase 1/2 trial, the companies said Tuesday. The patients had received a minimum two—and a median three—prior lines of systemic therapy. The median duration of response hasn’t been reached in Epkinly’s study, and investigators are still following patients. The companies also didn’t disclose the complete response rate. Full results from the study will be shared at a future medical meeting. Epkinly snagged an FDA approval for previously treated diffuse large B-cell lymphoma (DLCLC) in May, and AbbVie and Genmab said they will talk to regulators about next steps in FL, an indolent form of lymphoma. If approved in the ...
- Source: drugdu
- 109
- June 30, 2023
FDA Warms Up to Ipsen’s Post-Hoc Analysis for Rare Disease Drug Ahead of Adcomm

By Tristan Manalac https://www.biospace.com/ Despite a risk of bias and false positives, the FDA appears to be open to considering Ipsen’s post-hoc analysis of a Phase III study to support the approval of its investigational therapy palovarotene, proposed for the ultra-rare disease fibrodysplasia ossificans progressive. Ipsen is seeking approval for a once-a-day, 5-mg dose of palovarotene, along with a flare-up regimen consisting of a 20-mg once-daily schedule for the first four weeks followed by 10-mg once-daily for eight weeks, according to the company’s briefing document posted ahead of an Endocrinologic Drugs Advisory Committee meeting scheduled Wednesday. To support its regulatory bid, Ipsen provided data from one Phase II study with multiple open-label extension phases and a single-arm, open-label Phase III study, which used an external natural history control. However, according to the FDA’s briefing material, palovarotene failed its Phase III study, which “crossed the prespecified futility boundary at the second ...
- Source: drugdu
- 108
- June 29, 2023
Pfizer’s Litfulo approved by FDA as first treatment for adolescents with severe alopecia areata

Pfizer’s Litfulo (ritlecitinib) has been approved by the US Food and Drug Administration (FDA) as the first treatment option for patients aged 12 years and older with severe alopecia areata. Affecting almost seven million people in the US and approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body. The condition can develop at any age, with nearly 20% of patients diagnosed before the age of 18. Litfulo, which is a one-daily oral kinase inhibitor, is thought to work by blocking the activity of signalling molecules and immune cells believed to contribute to the loss of hair in patients with alopecia areata. Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, said: “Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options ...
- Source: drugdu
- 120
- June 29, 2023
Jazz brings the noise to the FDA with lawsuit over approval of Avadel’s narcolepsy drug Lumryz

After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.Jazz is challenging the regulator for approving Avadel Pharmaceuticals’ narcolepsy drug Lumryz, which poses a major threat to Jazz’s blockbuster Xyrem/Xywav franchise. In U.S. district court in Washington, D.C., Jazz claimed that the green light for Lumryz—which was awarded on May 1—was “unlawful.” The Dublin company says that the approval violated the orphan drug exclusivity (ODE) the agency granted to Xywav in 2021. In awarding Lumryz its own ODE, the FDA ruled that Lumryz is superior to Jazz’s offerings, citing its ability to make a major contribution to patient care based on its convenience and additional clinical benefit. While Lumryz is taken once a night, Xywav requires two doses. Both are oral suspension drugs. Jazz maintains that the FDA acted ...
- Source: drugdu
- 121
- June 28, 2023
Intercept restructures as Ocaliva’s NASH hopes dashed again with FDA rejection

Even after a second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Three years after an initial rejection, the FDA once again turned down Ocaliva, or obeticholic acid, for nonalcoholic steatohepatitis (NASH) patients with stage 2 or 3 liver fibrosis, Intercept said Thursday. The denial means patients with NASH will have to wait longer for the first FDA-approved therapy and that a market estimated to be worth multiple billions of dollars still awaits a winner. For Intercept, it also means it’s time for a new direction. Intercept has decided to discontinue all NASH-related investment and restructure its operations, with the goal to save about $140 million in operating costs, the company said Friday. Measures it’s taking include winding down a long-term patient outcomes follow-up of the phase 3 REGENERATE study for Ocaliva in NASH. All R&D, commercial, medical affairs and ...
- Source: drugdu
- 110
- June 27, 2023
Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval. David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018″. He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”. Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the ...
- Source: drugdu
- 108
- June 27, 2023
After delays, Sarepta’s DMD gene therapy Elevidys finally crosses FDA finish line at $3.2M

After several delays and a narrow advisory committee vote, Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has finally won an accelerated approval. The FDA’s approval for Elevidys comes one month behind the agency’s prior schedule and in a restricted patient population. But a win is a win for Sarepta. Specifically, the drug is approved to treat ambulatory patients ages 4 to 5 years with a confirmed mutation in the DMD gene. Sarepta is charging Elevidys, a one-time gene therapy, at a list price of $3.2 million, CEO Douglas Ingram told investors during a call Thursday. He pointed to an analysis suggesting the drug could be cost-effective at $5 million. Ingram expects the launch to take a few months to pick up, based on logistical and policy issues to address, he told investors. As opposed to an treatment outcome-based payment approach that has been adopted by other existing gene therapies to ...
- Source: drugdu
- 111
- June 26, 2023
FDA orders stores to stop selling Elf Bar disposable Vapes

The U.S. Food and Drug Administration said Thursday it has sent warning letters to 189 retailers, telling them to stop selling unauthorized tobacco products such as Elf Bar and Esco Bars. Both brands are disposable e-cigarettes sold in flavors known to appeal to kids, including bubblegum and cotton candy. A federal ban on flavored vapes that was issued in early 2020 does not cover disposable vapes. “The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” FDA Commissioner Dr. Robert Califf said in an agency news release. “We are committed to a multi-pronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.” The warning letters were sent following a nationwide inspection blitz conducted over several weeks. In addition, two studies published in Morbidity & Mortality Weekly Report highlight concerns ...
- Source: drugdu
- 117
- June 26, 2023
FDA Approves Sarepta’s Gene Therapy for Duchenne Muscular Dystrophy

By Heather McKenzie https://www.biospace.com/ Pictured: FDA sign in front of a brown brick building/Adobe Stock, Grandbrothers Sarepta’s Elevidys, approved Thursday as the first gene therapy for Duchenne muscular dystrophy, has been priced at $3.2 million per patient, making it one of the world’s most expensive medicines. The price, announced Thursday following the FDA’s decision, is second in the U.S. only to that of uniQure and CSL Behring’s hemophilia B therapy Hemgenix, approved late last year, which costs $3.5 million per patient, according to BioPharma Dive. On a conference call, Sarepta CEO Doug Ingram said the price reflected a “conservative” approach to valuing the therapy’s benefits to patients and their families, BioPharma Dive reported. Sarepta expects that discounts through Medicaid or a 340B program will make the net price of Elevidys about 20% lower than its gross cost. Original story published June 22 Sarepta’s Elevidys, approved Thursday, is now one of ...
- Source: drugdu
- 120
- June 25, 2023

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