Complete Response Letters

Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter. 

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

The drug maker said the US FDA issued a complete response letter for insulin icodec that included requests related to manufacturing process and the type 1 diabetes indication.

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.

While there were no issues of efficacy or safety behind a new US CRL for Daiichi Sankyo/Merck & Co's anti-HER3 antibody-drug conjugate patritumab, the FDA decision marks a hit to the companies' first ADC collaboration and the latest in a string of regulatory blows to Japanese firms in the US.

The US approval of HLB and Hengrui’s liver cancer combination therapy looks set to be delayed after the FDA issues a CRL related mainly to CMC data, but the two companies appear positive on a quick resolution to the setback given a lack of other efficacy or safety concerns.

Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.

Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.

Viatris offered little in the way of detail as it announced a setback for its Mapi Pharma-partnered proposed once-monthly glatiramer acetate product for relapsing forms of multiple sclerosis. The firm has previously shouted from the rooftops about Mapi’s Phase III clinical study and the potential to establish a new standard of care for glatiramer acetate patients.

Vanda CEO tells the Pink Sheet that the firm is going straight to appellate court to refute agency’s rejection of jet lag indication for Hetlioz. Similar battles may lie ahead over Vanda’s applications on Hetlioz for insomnia and tradipitant for gastroparesis.

Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.

US FDA’s drugs center posted one of its lowest monthly approval counts of original applications in January, but new indications filled the gap, including new claims for Merck’s Keytruda, Takeda immunoglobulins, and Sanofi/Regeneron’s Dupixent.

After a US FDA site inspection raised questions about the contract manufacturer of the potential first-in-class Claudin 18.2 inhibitor that could not be answered by the original January PDUFA date, Astellas will need to refile the application, but has not committed to when that might be.

Astellas has received a US CRL for it's potential first-in-class drug zolbetuximab, after questions over a manufacturing line came up after an FDA site inspection and could not be answered by the original 12 January PDUFA date. The Japanese firm will refile the application after resolving the issues, but the likely revised timeline is not yet clear.

US FDA’s biologics center posted a historic 17 novel approvals, blowing past previous records, while the drug center’s 55 novel agents was close to its 21st century high.

Aldeyra’s bid to rely on a single Phase III trial after an initial one failed is rejected by FDA, but firm already has a special protocol assessment under review for a trial that could provide the symptom data it says agency needs to approve the RASP modulator in dry eye. 

Aldeyra already has a special protocol assessment under review at the FDA for a trial to provide the symptom data the agency said is needed for approval of the RASP modulator in dry eye disease.