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An FDA safety probe into Takeda's Adzynma, Otsuka's IgAN approval for Voyxact and Daiichi Sankyo's latest win against Pfizer made our news this week. The FDA is investigating a safety signal from Takeda’s rare disease med Adzynma. Otsuka won a first-in-class FDA approval to enter the crowded IgA nephropathy field. Daiichi Sankyo won reversal of an unfavorable ruling in its patent fight against Pfizer’s Seagen. And more.1. FDA launches investigation into Takeda's Adzynma following reported pediatric deathThe FDA is investigating Takeda’s Adzynma following a reported child's death. The drug, approved for the rare blood disorder congenital thrombotic thrombocytopenic purpura, is under scrutiny due to postmarketing reports of patients developing neutralizing antibodies against the drug’s ADAMTS13 protein ingredient. Takeda said it found no confirmed causal link.2. In crowded kidney disease space, Otsuka receives FDA approval for first-in-class VoyxactOtsuka received accelerated FDA approval for Voyxact (sibeprenlimab) to treat IgA nephropathy (IgAN). The monthly self-administered drug is the first biologic cleared for the kidney disease and the first to block the APRIL protein. Before entering a competitive market, Voyxact showed a placebo-adjusted 51% reduction in proteinuria at nine months in a phase 3 trial.3. Daiichi Sankyo prevails on appeal in long-running ADC patent battle with Seagen, flipping prior $41.8M verdictDaiichi Sankyo got a win in its long-running antibody-drug conjugate patent dispute with Pfizer’s Seagen. The U.S. Court of Appeals reversed a prior ruling that found Daiichi infringed a Seagen patent with Enhertu. The new decision nullifies a previous Texas court verdict, which said Daiichi owed Seagen royalties related to the popular ADC.4. Crescent waxes pipeline with $80M Kelun deal, bagging ADC to pair with PD-1xVEGF bispecificCrescent Biopharma struck a $80 million upfront deal for ex-China rights to Kelun-Biotech’s integrin beta-6-directed ADC candidate. Crescent plans to test the new ADC in combination with its own PD-1xVEGF bispecific antibody for solid tumors. In exchange, Kelun will pay $20 million upfront for Chinese right to Crescent’s bispecific. 5. Merck's partner Kelun touts phase 3 win for ADC-Keytruda combo in first-line lung cancerKelun also reported a phase 3 win for its Merck & Co.-partnered TROP2 ADC, sacituzumab tirumotecan (sac-TMT), combined with Keytruda. The combo significantly improved progression-free survival versus Keytruda alone in Chinese patients with first-line PD-L1-positive non-small cell lung cancer, according to Kelun.6. FDA grants game-changing perioperative approval to Padcev, Keytruda combo in bladder cancerA combination of Astellas and Pfizer’s Padcev and Keytruda won an FDA approval as a perioperative treatment for muscle-invasive bladder cancer patients ineligible for cisplatin chemotherapy. The regimen, used around surgery, is the first to significantly improve survival over surgery alone in this population, reducing the risk of death by 50% in a phase 3 trial.7. Daiichi Sankyo receives FDA untitled letter taking aim at Turalio patient ambassador videoSK Life Science Xcopri ad meets a roadblock with FDA untitled letterThe FDA issued separate untitled letters to Daiichi Sankyo and SK Life Science over “false or misleading” drug marketing. The letter to Daiichi cited a Turalio patient ambassador video that overstated treatment benefits, while the letter to SK Life Science took aim at a TV ad for the anti-seizure drug Xcopri for omitting major risk warnings and failing to present risk information concurrently in both audio and text.Other News of Note: 8. FDA floats user fee cuts for early-stage US trials, additional fees for overseas development9. After dodging Biosecure threat, WuXi AppTec faces new security scrutiny from Pentagon: Bloomberg10. Tanabe Pharma shifts gears for Bain-backed future, dropping Mitsubishi moniker after $3.3B deal11. Sun Pharma shines a light on diabetic retinopathy in #SeeBeyondSugar campaign12. Pfizer, GSK, Shionogi sponsor London run of musical about antimicrobial resistance13. Eisai finalizes FDA filing for subcutaneous Leqembi starter dose (Regulatory tracker)14. China launches national drug price registration system (Yicai)

Dive Brief:The Food and Drug Administration is investigating the safety of a Takeda Pharmaceutical medicine for a rare blood clotting disorder, after the death of a pediatric patient.Adzynma won FDA approval in 2023 to treat adults and children with congenital thrombotic thrombocytopenic purpura. The drug is a genetically engineered version of a blood-clotting enzyme that is deficient in these patients, and designed to prevent complications that, left untreated, have a 90% mortality rate. The clearance included both prophylactic and on-demand treatment with the medicine.On Friday, the FDA announced it has received reports that patients treated with Adzynma developed antibodies that neutralize these enzymes, and the pediatric patients death appears to be related to Adzynma. Takeda said there has been no confirmed causal relationship between the death and the companys medicine.Dive Insight:The FDA was concerned enough about the reports to issue a safety communication and is evaluating whether to take further regulatory action. But the agency also said currently available assays cant distinguish between the neutralizing antibodies that target the lab-created enzyme or those that go after the naturally occurring enzymes.There were no reports of neutralizing antibodies in the clinical studies Takeda submitted to support approval of its drug, though the prescribing information does contain a warning about the potential risk of developing them. The presence of neutralizing antibodies was identified in the patient who died about 10 months after treatment started, the FDA said.Takeda learned of the patient death in July and reported it to the FDA while also conducting a thorough assessment on its own that found no link to Adzynma. The health and safety of the patients we serve is our top priority and we are saddened by the death of this patient, the company said Friday. There are no changes to the overall risk/benefit profile of Adzynma at this time.Patients with concerns about their treatment regimen should speak to their healthcare providers, the company added. Adzynma is not a major seller for Takeda, bringing in 4.8 billion yen, or roughly $32 million, in the first half of the Japan-based companys current fiscal year. '