FDA Updates for Week of Sept. 5, 2022

September 10, 2022

In COVID-19 information, the FDA indicated Eiger’s remedy not supported by knowledge. An advisory committee switched its vote to sure for brand spanking new ALS drug. The FDA accepted Stimufend, a biosimilar to Neulasta, in addition to Imfinzi for biliary tract most cancers, a longer-lasting remedy for frown traces, an oral suspension for gastric ulcers, and generics of Revlimid. The company accepted purposes for novel dry eye illness and alopecia therapies. Moreover, Seres accomplished rolling BLA for microbiome therapeutic.

FDA advisory committee helps approval of AMX0035 for ALS.

Regardless of extra knowledge that some members stated solely added modestly to the proof, an FDA advisory committee voted to assist approval of Amylyx’ AMX0035 (sodium phenylbutyrate and taurursodiol). In a 7 to 2 vote, the Peripheral and Central Nervous System Medication Advisory Committee late on Wed. Sept. 7, 2022, supported approval of Amylyx Prescription drugs’ remedy to deal with sufferers with amyotrophic lateral sclerosis (ALS).

Whereas not binding, the committee’s advice might be thought of by the FDA in its evaluation of the pending new drug software (NDA) for AMX0035.The Prescription Drug Consumer Payment Act (PDUFA) goal motion date is Sept. 29, 2022.

This was the second time the advisory committee thought of the query of whether or not the info assist the effectiveness of AMX0035. On the first advisory committee assembly in March 2022 during which six of the ten members voted no on the query of whether or not the open-label extension of the section 2 CENTAUR trial established a conclusion that AMX0035 is efficient within the remedy of sufferers with ALS.

After Wednesday’s vote, a number of committee members talked about they have been swayed partly by the extra evaluation introduced by Amylyx. Some indicated the unmet and the seriousness of ALS, in addition to encouraging indicators from the continuing section 3 PHOENIX trial, inspired them to change their no votes to sure.

AMX0035 is accepted in Canada with the model identify Albrioza, and a advertising software can also be pending in Europe.

FDA approves Stimufend, a biosimilar to Neulasta.

The FDA has accepted Fresenius Kabi’s biosimilar Stimufend (pegfilgrastim-fpgk) to be used in sufferers with non-myeloid malignancies receiving myelosuppressive anti-cancer medicine related to a clinically important incidence of febrile neutropenia. The corporate expects to launch the product as a prefilled syringe early subsequent 12 months. Stimufend is a biosimilar of Amgen’s Neulasta. The corporate can also be creating on-body injector for Stimufend.

Stimufend is Fresenius Kabi’s first U.S.-approved remedy in its biosimilar portfolio.

Pegfilgrastim biosimilar is a supportive care medication for sufferers with non-myeloid most cancers. It stimulates the expansion of sure white blood cells, that are important to stop or combat infections, a standard life-threatening threat in sufferers receiving myelosuppressive chemotherapy.

The approval for Stimufend is predicated on a evaluation of a complete knowledge bundle and a totality of proof that demonstrated a excessive diploma of similarity with the reference product.

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FDA: Eiger’s COVID-19 remedy not supported by knowledge.

The FDA is requiring extra knowledge and knowledge on Eiger BioPharmaceuticals’ request for emergency use authorization (EUA) of peginterferon lambda to deal with sufferers with mild-to-moderate COVID-19. Following a pre-EUA data trade with the FDA concerning the section 3 TOGETHER examine of peginterferon lambda for COVID-19, the company has indicated that it’s not but capable of decide whether or not the standards for the submission of an software and issuance of an EUA are more likely to be met.

The corporate has generated new knowledge and analyses from the TOGETHER examine that it plans to debate with FDA, together with additional statistical modeling and efficacy analyses of the examine’s main and secondary endpoints in sufferers handled inside three days of symptom onset. The endpoint of hospitalization as a result of COVID-19 and all-cause mortality for sufferers handled inside three days of symptom onset is in keeping with the endpoint used to authorize different therapeutics for emergency use.

The unique efficacy evaluation of the info generated from the TOGETHER examine was based mostly on dosing peginterferon lambda inside seven days of symptom onset. Eiger additionally plans to offer the FDA new extra analyses of long-term follow-up knowledge, together with charges of rebound and incidence of lengthy COVID, in addition to an oblique comparative evaluation of mortality and hospitalizations in vaccinated sufferers when handled with peginterferon lambda in contrast with different therapeutics licensed for emergency use.

Peginterferon lambda is a first-in-class, kind III interferon that stimulates immune responses which can be crucial for the event of host safety throughout viral infections. Eiger licensed worldwide rights to lambda from Bristol Myers Squibb.

FDA approves Imfinzi for metastatic biliary tract most cancers.

The FDA has accepted AstraZeneca’s Imfinzi (durvalumab) to deal with grownup sufferers with domestically superior or metastatic biliary tract most cancers together with chemotherapy (gemcitabine plus cisplatin). Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interplay of PD-L1 with the PD-1 and CD80 proteins.

Biliary tract most cancers is a gaggle of uncommon and aggressive cancers. About 23,000 folks in america are identified with these cancers annually. These sufferers have a poor prognosis, with about 5% to fifteen% of sufferers surviving 5 years.

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The approval was based mostly on the outcomes from the TOPAZ-1 section 3 trial. In an interim evaluation, Imfinzi plus chemotherapy lowered the chance of dying by 20% versus chemotherapy alone. An estimated one in 4 sufferers handled with Imfinzi plus chemotherapy have been nonetheless alive at two years in contrast with one in 10 handled with chemotherapy alone.

In July 2022, Imfinzi plus chemotherapy was added to the NCCN Medical Observe Pointers in Oncology as a Class 1 most popular routine as 1st-line remedy for domestically superior or metastatic biliary tract most cancers based mostly on the info from TOPAZ-1.

FDA approves oral suspension for gastric ulcers.

The FDA has accepted Azurity Prescription drugs’ Konvomep (omeprazole and sodium bicarbonate). Konvomep is an oral suspension to deal with lively benign gastric ulcer and discount of threat of higher gastrointestinal bleeding in critically in poor health sufferers. Azurity officers count on Konvomep will grow to be commercially out there within the first quarter of 2023.

In July 2022, the FDA accepted Azurity’s Zonisade, an oral suspension of zonisamide to deal with partial seizures in adults and pediatric sufferers aged 16 years and older with epilepsy. That is the primary oral liquid type of zonisamide.

FDA approves longer-lasting remedy for frown traces.

The FDA has accepted Daxxify (daxibotulinumtoxinA-lanm) for injection for the non permanent enchancment of moderate-to-severe frown traces (glabellar traces) in adults. Developed by Revance Therapeutics, Daxxify is an acetylcholine launch inhibitor and neuromuscular blocking agent stabilized with the corporate’s Peptide Trade Expertise. It is freed from each human serum albumin and animal-based parts.

The approval was based mostly on the info generated within the SAKURA section 3 scientific trial program (SAKURA 1,2,3). The median period of effort was six months. Some sufferers maintained remedy outcomes at 9 months, with outcomes seen as early as in the future after remedy, usually seen inside two days.

FDA, EMA settle for submissions for alopecia remedy.

The FDA has accepted for Pfizer’s new drug software (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The FDA is predicted to decide within the second-quarter 2023. Moreover, the European Medicines Company (EMA) has additionally accepted the advertising authorization software (MAA) for ritlecitinib in the identical affected person inhabitants with a call anticipated within the fourth-quarter 2023.

Alopecia areata is an autoimmune illness the place the immune system assaults the physique’s hair follicles, inflicting hair to fall out. Alopecia areata impacts about 6.8 million folks in america and round 147 million folks globally.

Ritlecitinib is an investigational oral, once-daily remedy that’s the first in a brand new class of oral extremely selective kinase inhibitors that may be a twin inhibitor of the TEC household of tyrosine kinases and of Janus kinase 3 (JAK3).

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FDA accepts NDA for novel dry eye illness remedy.

The FDA has accepted Bausch + Lomb’s new drug software (NDA) for NOV03 (perfluorohexyloctane) related to Meibomian gland dysfunction (MGD). The remedy is a first-in-class eye drop with a novel mechanism of motion. It prevents extreme tear evaporation and has the flexibility to restores tear movie steadiness. It stabilizes the lipid layer for hours to guard the tear movie and has the flexibility to penetrate the Meibomian glands. NOV03 has been assigned a Prescription Drug Consumer Payment Act (PDUFA) motion date of June 28, 2023.

Bausch + Lomb submitted the NDA for NOV03 in July 2022 based mostly on two pivotal section 3 trials, (GOBI and MOJAVE), each of which demonstrated statistically important enchancment vs. management for each main and key secondary signal and symptom endpoints.

Seres completes rolling BLA for microbiome therapeutic.

Seres Therapeutics has accomplished the rolling submission course of for its biologics license software (BLA) to the FDA for SER-109 for the prevention of recurrent C. difficile an infection. C. difficile is a bacterium that causes diarrhea and colitis. The CDC estimates that there are about half one million infections a 12 months, and one in six sufferers may have a second an infection inside two to eight weeks. In these over the age of 65, one in 11 sufferers with C. difficile will die inside one month.

SER-109 is an oral microbiome therapeutic consisting of a purified Firmicutes spores, which usually stay in a wholesome microbiome. SER-109 is designed to modulate the disrupted microbiome in order that it resists C. difficile progress. The SER-109 manufacturing purification course of is designed to take away undesirable microbes, lowering the chance of pathogen transmission

Dr. Reddy’s launches, Cipla receives approval for generic Revlimid.

Dr. Reddy’s Laboratories has launched lenalidomide capsules, a generic equal of Bristol Myers Squibb’s Revlimid (lenalidomide) capsules, which is used to deal with sufferers with a number of myeloma, mantle cell lymphoma, and myelodysplastic syndromes, as a upkeep remedy following stem cell transplant.

Dr. Reddy’s acquired a first-to-market 180 days of exclusivity for the two.5 mg and 20 mg strengths. Dr. Reddy’s lenalidomide is accessible in strengths of two.5 mg, 5 mg, and 10 mg in a bottle-count dimension of 28, in addition to 15 mg, 20 mg, and 25 mg strengths, every in a bottle-count dimension of 21.

Moreover, the FDA accepted Cipla’s generic model of Revlimid capsules in 5 mg, 10 mg, 15 mg and 25 mg strengths. The corporate stated the product might be transport quickly. Teva Prescription drugs grew to become the primary to launch a generic of Revlimid in March 2022 in 5 mg, 10 mg, 15 mg, and 25 mg strengths.