Traditional Drug Pipeline Update: January 2023

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate articles for pipeline information on specialty drugs.

New Drug Information

• Iyuzeh^®(latanoprost) ophthalmic solution 0.005%: The U.S. Food and Drug Administration (FDA) has approved Thea Pharma’s Iyuzeh for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Iyuzeh is the first preservative-free formulation of latanoprost. Iyuzeh was approved based on clinical trials of patients with open-angle glaucoma or ocular hypertension with mean baseline IOP of 19-24 mmHg. Iyuzeh lowered IOP by 3-8 mmHg versus 4-8 mmHg by Xalatan^® (latanoprost ophthalmic solution) 0.005%.¹ Iyuzeh is scheduled to launch in the second half of 2023 with pricing to follow.
• Sunlenca^® (lenacapavir): Gilead Sciences’ Sunlenca has been granted approval by the FDA in combination with other antiretroviral(s) (ARV), for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection. Sunlenca offers a twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen. The initial doses of Sunlenca are given as oral tablets and injections to get the drug up to therapeutic levels quickly, followed by injections every six months to sustain the treatment. Sunlenca was approved based on the Phase 2/3 CAPELLA trial, which evaluated Sunlenca in combination with an optimized background regimen in people with multi-drug resistant HIV-1 who are heavily treatment experienced. Eighty-three percent of patients treated with Sunlenca in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 52. Additionally, patients treated with Sunlenca achieved a mean increase in CD4 count of 82 cells/µL.² Sunlenca has launched with a wholesale acquisition cost (WAC) $812.50 per tablet ($3,250-$4,062.50 per pack) and $19,500 per vial ($3,250 per 30 days for maintenance). Sunlenca injection and tablets are expected to cost $42,250 in the first year of therapy and $39,000 annually after that.
• Airsupra^® (albuterol and budesonide): The FDA approved AstraZeneca’s Airsupra (albuterol and budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the United States. Airsupra’s approval was based on results from Phase 3 clinical trial MANDALA, that demonstrated compared to albuterol rescue, Airsupra at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% in adults and adolescents.³ Airsupra launch and price are pending.
• Rykindo^® (risperidone) for extended-release injectable suspension: The FDA has approved Luye Pharma’s Rykindo for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. Rykindo is administered as an intramuscular injection once every two weeks. Rykindo was approved via the 505(b)2 pathway using Alkermes’ Risperdal Consta (risperidone) as its reference product.⁴ Rykindo launch and price are pending.

 Generic Drug Information

• Trokendi XR^® (topiramate cap ER 24HR, 25mg, 50mg, 100mg): Zydus has launched their generic version of Supernus Pharmaceuticals’ Trokendi XR (topiramate cap ER 24HR, 25mg, 50mg, 100mg) for the treatment of epilepsy: initial monotherapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS). Trokendi XR is also indicated for prophylaxis of migraine in patients 12 years of age and older. Multiple manufacturers are planning to launch their generic versions this year. Trokendi XR generated $584 million in U.S. annual sales in 2021.
• Hetlioz^® (taimelteon 20mg): Teva launched their generic version of Vanda Pharmaceuticals’ Hetlioz for the treatment of non-24-hour sleep-wake disorder (Non-24) in adults, and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. Hetlioz generated less than $10 million in U.S. annual sales in 2021.
• Amitiza^® (lubiprostone cap, 8mcg, 24mcg): Teva launched their generic version of Takeda’s Amitiza for the treatment of chronic idiopathic constipation in adults and treatment of irritable bowel syndrome with constipation in women ≥ 18 years old. Amitiza generated $135 million in U.S. annual sales in 2021.
• Cambia^® (diclofenac packet 50mg): Ascend Laboratories launched their generic version of Assertion Therapeutics’ Cambia for acute treatment of migraine attacks with or without aura in adults 18 years of age or older. Cambia generated $42 million in U.S. annual sales in 2021.
• Mirvaso gel^®33% (brimonidine tartrate gel 0.33%): Padagis launched their generic version of Galderma’s Mirvaso indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. Mirvaso gel generated $11 million in U.S. annual sales in 2021.
• Esbriet^®+ (pirfenidone capsule 267mg): Sandoz has launched their generic version of InterMune/Genentech’s Esbriet (pirfenidone capsule 267mg) for the treatment of idiopathic pulmonary fibrosis (IPF). Multiple manufacturers are planning to launch their generic versions this year. Esbriet generated $867 million in U.S. annual sales in 2021.
• Treanda^®+ (bendamustine IV soln 25mg, 100mg): Accord has launched its generic version of Cephalon/Teva’s Treanda for chronic lymphocytic leukemia (CLL). Also indicated for indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Treanda generated $69 million in U.S. annual sales in 2021.

+Specialty medication

References

1. https://eyewire.news/news/thea-pharma-announces-fda-approval-of-glaucoma-drug-iyuzeh?c4src=article:infinite-scroll
2. https://www.gilead.com/news-and-press/press-room/press-releases/2022/12/sunlenca-lenacapavir-receives-fda-approval-as-a-firstinclass-twiceyearly-treatment-option-for-people-living-with-multidrug-resistant-hiv
3. https://www.prnewswire.com/news-releases/avillion-announces-us-approval-of-astrazenecas-airsupra-pt027-as-new-rescue-treatment-for-asthma-301719122.html
4. https://www.prnewswire.com/news-releases/fda-approves-luye-pharmas-rykindo-for-the-treatment-of-schizophrenia-and-bipolar-1-disorder-301721891.html