| |DECEMBER 20259ELI LILLY REACHES $1 TRILLION ON SURGING WEIGHT-LOSS DRUG SALESTAKEDA'S ADZYNMA UNDER FDA SCRUTINY FOLLOWING PEDIATRIC FATALITYEli Lilly has become the first drugmaker to reach a $1 trillion market valuation, driven by soaring demand for its weight loss and diabetes drugs.This ascension is indicative of how the weight-loss drug market, which was initially a niche, has become one of the most lucrative health care markets.The shares of the company have increased more than 35 per cent this year, which is in large part due to the huge sales of tirzepatide, branded as Mounjaro to treat type 2 diabetes and Zepbound to treat obesity.Over half of its entire revenue in its most recent quarter came out to in excess of 10.09 billion US dollars in combined revenue of these metabolic-health treatments at Lilly.Its execution is also a contributor to the meteoric rise of Lilly. Although Novo Nordisk initially led in obesity medication, the Limited availability and slower scale-up of it enabled Lilly to take the lead. Lilly is now seen by investors as a potential metabolic health leader over long term and Wall Street estimates peg global weight-loss drug market at approximately 150 billion by 2030 is one area where Lilly will be in a good position to lead.Lilly is also preparing to introduce orforglipron, its oral obesity medication, and this will allow Lilly to expand its reach to a large extent. Meanwhile, the company has negotiated with the government of the U.S. to reduce prices of Mounjaro and Zepbound- a step that can narrow the margin yet widen the access. Analysts are observing the ability of Lilly to keep this wave going as it ramps up production and avoids pricing pressures. POThe FDA has launched a formal investigation into Takeda's rare-disease therapy Adzynma, following the death of a pediatric patient who developed neutralizing antibodies to the ADAMTS13 enzyme, according to a safety communication issued on November 21, 2025.Adzynma, approved in 2023 for congenital thrombotic thrombocytopenic purpura (cTTP), replaces the missing ADAMTS13 protein to manage cTTP's dangerous clotting risks.The FDA says it has since received multiple post-marketing reports of patients forming neutralizing antibodies--something that did not emerge in clinical trials.In the fatal case, the child experienced progressively worsening neurological symptoms about 10 months after starting treatment and was found to have antibodies that blocked ADAMTS13 activity. Notably, assays currently used by the FDA cannot distinguish between antibodies against the recombinant enzyme and those targeting the body's own ADAMTS13, complicating the risk assessment.Takeda responded by saying it reported the event to the FDA in July and has since provided updates. The company also stated that its internal review found no proven causal link between Adzynma and the death, and it believes the overall risk-benefit profile of the drug remains unchanged.From an industry perspective, this probe could carry major implications. Adzynma is one of the few targeted therapies for cTTP--a rare but life-threatening clotting disorder. Regulators may now demand updated labeling, stronger warnings, or additional post-marketing studies to better track immunogenicity in real-world use. PO
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