Follitropin delta

Before Incyte, Novo Nordisk's legacy Catalent site triggered complete response letters for Regeneron and Scholar Rock. Issues at a former Catalent plant now owned by Novo Nordisk have derailed another FDA application, with Incyte announcing Friday that the FDA handed over a complete response letter for its PD-1 inhibitor Zynyz as a first-line treatment for non-small cell lung cancer (NSCLC).The rejection was not related to any efficacy or safety concerns but rather inspection findings at a fill-finish facility—specifically, the former Catalent plant in Bloomington, Indiana, which is now owned by Novo as part of Novo Holdings’ $16.5 billion acquisition of the CDMO in 2024.The setback comes more than a year after Incyte detailed a 25% reduction in the risk of death for a combination of Zynyz and chemotherapy versus chemo alone among patients with newly diagnosed metastatic NSCLC in the phase 3 Pod1um-304 trial. By clearing that clinical hurdle, Incyte was poised to enter the lucrative first-line NSCLC market, only to be tripped up now by a manufacturing site that has created headaches for several biopharma companies.Incyte joins a growing list of drugmakers that have seen regulatory timelines delayed by compliance issues at Novo’s Indiana site, referred to as Catalent Indiana in Incyte’s filing. Last year, the facility yielded a pair of CRLs for Regeneron, with one for high-dose Eylea and the other for blood cancer bispecific odronextamab.Scholar Rock also received a CRL last year thanks to production issues at the ex-Catalent plant, with the company’s spinal muscular atrophy candidate apitegromab denied approval in September. Problems at the Indiana plant culminated in an FDA warning letter in November. During an inspection in the summer of 2025, the FDA found that the facility failed to properly investigate more than 20 deviations linked to possible contamination of drug product from mammalian hair contamination in or around the stopper region of vials.In a March 9 statement to Fierce Pharma, a Novo spokesperson said the company is “actively engaging with the agency to address its findings.”The FDA issued its CRL to Incyte on Feb. 27. The agency delivered another manufacturing-related CRL on the same day to Ferring Pharmaceuticals, hitting the firm’s human recombinant follicle simulating hormone follitropin delta (FE 999049), which is being developed for women undergoing uncontrolled ovarian stimulation. The drug is approved under the brand name Rekovelle in several international markets, such as the EU. Ferring’s trouble doesn’t seem to come from the Catalent Indiana site. While the Novo manufacturing site’s censure is not related to a specific product, the Ferring CRL followed deficiencies uncovered during a pre-license inspection of a facility, which led to an FDA Form 483, according to the CRL published (PDF) by the FDA.Fierce Pharma has reached out to Ferring for comment. As to Incyte, the impact of the CRL is limited. Although first-line NSCLC is the largest indication in oncology, Merck & Co.’s deeply entrenched Keytruda leaves little room for another PD-1 in most developed markets.  Zynyz got its initial FDA nod last year, becoming the first treatment specifically approved in first-line anal cancer. Incyte also announced Friday that the European Commission has authorized the drug for the same use.Following its May 2025 nod, Zynyz brought in $66.4 million in sales last year. Incyte’s former CEO Hervé Hoppenot previously told Fierce that the company does not expect the PD-1 inhibitor to be a major revenue driver but noted that U.S. approvals may be used as reference for regulators at certain emerging markets. Editor's Note: The story was updated at 2:45 p.m. ET with a statement from Novo Nordisk.

More than 20% of employees said they feel unsupported in the workplace regarding fertility treatment. A Ferring Pharmaceuticals survey has found 39% of people undergoing fertility treatment are at least considering leaving their jobs, leading the drugmaker to question whether companies are doing enough to support employees. Ferring funded the survey and worked with Fertility Matters at Work and This Can Happen, groups that offer workplace support, on the project. Having initially targeted the U.K., the survey expanded to include Australia, France, Japan and Poland and to cover more than 3,600 employees and employers. The goal was to explore how fertility challenges affect people at work and what employers can offer.Two-thirds of respondents who have faced fertility challenges said their workplaces don’t offer support for employees undergoing fertility treatment. Support is rarest in France, where 88% of respondents said their employers lacked initiatives to help workers receiving fertility treatment.The survey found 60% of respondents lacked clear entitlement to time off for fertility appointments. The situation led people undergoing fertility treatment to record time off for appointments as paid, unpaid or annual leave. Almost 20% of respondents said the lack of flexibility led them to take sick leave. The presence or absence of support is informing decisions about where to work. Beyond finding that 39% of people undergoing fertility treatment are leaving or considering quitting their jobs, the survey revealed widespread interest in roles that provide fertility support. Almost three-quarters of people who are experiencing fertility challenges would be attracted to roles that provide support.While 75% of employers said they recognize fertility treatment as a significant life event, only 27% of employees who have experienced fertility challenges agree. More than 20% of employees said they feel unsupported, and 36% have felt pressure from their employer to work while undergoing treatment or investigations. Mental well-being is a particular concern for people undergoing fertility treatment.Signs suggest uptake of fertility treatment could increase. Babies conceived using assisted reproductive technology accounted for 2.6% of births in the U.S. in 2022. The figure rises to around 10% in Denmark and 12% in Spain. President Donald Trump acted to increase access to fertility care in the U.S. in October, including by inking a drug pricing deal with Merck KGaA's EMD Serono.Like EMD Serono, Ferring sells fertility drugs. Ferring’s portfolio includes the recombinant human follicle-stimulating hormone Rekovelle, which competes with drugs including the Gonal-f product covered by Trump’s deal with EMD Serono.