Ivermectin

Adalvo, in partnership with STADA, announces the commercial launch of generic Ivermectin 10mg/g (1%) cream in Germany. It is believed to be the first generic alternative to Soolantra (Galderma) available to patients in Europe. Ivermectin cream is indicated for the treatment of inflammatory lesions – the pimples and spots associated with rosacea, a condition affecting an estimated 5% of the global population, which can significantly impact quality of life. Ivermectin cream, with its dual anti-inflammatory and antiparasitic mechanism of action, has become an important option in managing the condition. The availability of Adalvo’s generic represents a meaningful step towards broader patient access to an established, well-regarded therapy with sustained demand. Working alongside STADA, one of Europe's leading generics and branded medicines companies, Adalvo has delivered on the Day-1 launch ambition. “Through our partnership with Adalvo, we are bringing a high-quality, affordable treatment option to patients in Germany, while equipping physicians and pharmacists with a reliable option to support patient care,” commented Basem Yazgi, General Manager of STADA’s ALIUD PHARMA German generics business. Anil Okay, Adalvo’s CEO, said: “This launch is another great example of the value Adalvo offers our partners: early market entry with a high-quality product that lowers costs for those who are most in need, while helping partners gain a strong foothold.” Adalvo's dermatology portfolio continues to expand, with Ivermectin cream joining Adapalene + Benzoyl Peroxide Gel, Tacrolimus Ointment, and Apremilast film coated tablets. To discuss licensing or commercial opportunities within Adalvo's dermatology portfolio, contact the team today.

China’s National Medical Products Administration has approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis, making it the first therapy approved in China for Demodex blepharitis that targets the root cause of the condition. The approval, obtained by Grand Pharmaceutical Group Limited, triggers a USD 15 million milestone payment to Tarsus Pharmaceuticals, which developed the drug under the designation TP-03 and holds the US FDA approval for the same indication granted in July 2023. Lotilaner remains the only approved prescription treatment for Demodex blepharitis in any regulatory jurisdiction worldwide. The NMPA approval covers the People’s Republic of China, with Grand Pharma holding exclusive rights to develop and commercialize TP-03 across the Greater China region, including Hong Kong, Macau, and Taiwan. Grand Pharma acquired these rights from LianBio through a novation agreement executed in March 2024, assuming all obligations under the original licensing deal between LianBio and Tarsus. Under the agreement, Tarsus is eligible for additional regulatory milestones, sales threshold milestones, and tiered royalties on product sales in the region, the company said. The US FDA approval in 2023 was based on data from two Phase II/III randomized, controlled trials, Saturn-1 and Saturn-2, which enrolled patients with Demodex blepharitis. In those studies, lotilaner ophthalmic solution administered as one drop in each eye twice daily for six weeks demonstrated statistically significant rates of collarette cure — complete resolution of the cylindrical dandruff formations at the lash base that are the hallmark clinical sign of Demodex infestation. Approximately 44% of treated patients achieved collarette cure compared with roughly 7% receiving vehicle, and around 60% of patients had no detectable Demodex mites following treatment. The drug also showed significant improvements in erythema cure. The most common adverse reaction was instillation site stinging or burning. Specific clinical trial data supporting the Chinese regulatory submission were not detailed in the announcement, though the approval references the same molecule and formulation evaluated in the Saturn program. Demodex blepharitis is a chronic inflammatory eyelid condition driven by infestation with Demodex folliculorum and Demodex brevis mites. The company’s announcement references more than 40 million affected individuals in the Greater China region. Before lotilaner’s arrival, management relied on off-label approaches — tea tree oil lid scrubs, topical or oral ivermectin, lid hygiene regimens, and in-office mechanical debridement — none of which carried regulatory approval for the indication or directly eradicated the mites. Lotilaner is an isoxazoline compound originally developed by Elanco as a veterinary ectoparasiticide. It acts as a non-competitive antagonist of invertebrate gamma-aminobutyric acid-gated chloride channels, a target absent in mammalian GABA receptors, causing paralysis and death of the mites. Tarsus licenses the underlying intellectual property from Elanco Tiergesundheit AG for human health applications. No other novel molecules are in late-stage clinical development specifically for Demodex blepharitis. Tarsus is separately advancing TP-04, a related compound in Phase II for ocular rosacea, and TP-05, an oral tablet in Phase II for prevention of Lyme disease. The broader ocular surface landscape has seen recent approvals for adjacent conditions — including Miebo for dry eye disease associated with meibomian gland dysfunction and Vevye for dry eye disease, both approved in 2023 for dry eye disease. The China approval extends the geographic reach of the only targeted pharmacotherapy for a condition that has historically been under-diagnosed and managed without standardized treatment protocols. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website