Month: April 2025

The FDA recently approved a new therapy originally approved in 2006, Susvimo (ranibizumab) from Genentech, an ocular implant providing customized therapy for diabetic macular edema (DME). This therapy has been granted a new indication and approved an updated delivery system.

Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. 

Susvimo is the first and only FDA-approved treatment shown to maintain vision for patients with DME. Susvimo is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.

DME is the leading cause of vision loss for patients with diabetes affecting 12% of type 1 and 28% of type 2 diabetic patients. The lifetime risk of developing DME for people with diabetes is about 10%.

Genentech originally confirmed pricing for the implant and Susvimo at $16,950 the first year, and two refills every six months in year two are priced at $16,000.

Genentech did not announce details for distribution.

CLICK HERE to access prescribing information

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FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness

• Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)
• With as few as two treatments per year, Susvimo may help people with DME maintain their vision
• Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD)

CLICK HERE to read the full press release

The FDA recently approved another biosimilar, Avtozma (tocilizumab-anoh) from Celltrion, as a third biosimilar to Actemra. As with the reference brand, Avtozma is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19).

Avtozma is available in both intravenous (IV) and subcutaneous (SC) formulations. Approval for Avtozma specifies infused administration for RA. The other approved indications are eligible for SC administration.

Avtozma was also approved with a Black Box Warning similar to the reference product.

Dosing of Avtozma is weight based and varies widely by disease indication and dosing schedule. Dosing strength varies widely, from as little as 12mg (juvenile) to 162mg (recommended adult dosing).

Genentech announced that the average monthly cost of Actemra administered via IV runs between $2,308 to $4,616, depending on dose a person receives. The average monthly cost of Actemra administered subcutaneously ranges from about $2,478 to $4,956 based indication and frequency.

CLICK HERE to access prescribing information

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U.S. FDA approves Celltrion’s AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA

CLICK HERE to access the article

The FDA recently approved a very old drug, Spravato (esketamine) from Janssen Pharmaceuticals, for a very new indication. Esketamine was originally approved by the FDA in 1970, a mere 35 years ago!

Spravato is indicated for the treatment of:

• Treatment-resistant depression (TRD) in adults, as monotherapy or in conjunction with an oral antidepressant.

• Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.

Spravato (56mg or 84mg) is administered intranasally and only under the supervision of a healthcare provider. It was approved with a Black Box Warning and an associated REMS program. Dosing is twice weekly in weeks 1-4, once weekly in weeks 5-8, and once every two weeks in weeks 9 and after.  

The cost of Spravato ranges between $700 and $1200 per dose. 

Year 1 cost will range between $23,800 (56mg) and $40,800 (84mg).

Janssen also announced specialty pharmacy distribution options as follows;

“The specialty pharmacy pathway is the process of acquiring Spravato through a REMS-certified specialty pharmacy. This pathway allows treatment centers to treat patients who are covered under the pharmacy benefit. The pharmacy pathway does not require your treatment center to purchase Spravato but does require shipment coordination before each treatment session. Using the specialty pharmacy pathway, your treatment center receives patient-assigned product from a REMS-certified pharmacy and bills only for associated healthcare services.”

The following SPs are REMS certified and were included because of their geographic coverage, health plan coverage, and fulfillment capabilities.

• AllianceRX — (Walgreens/Prime)
• CVS Specialty — (CVS Caremark)
• Humana Specialty — (Humana)
• AcariaHealth —  (Centene)

CLICK HERE to access the J&J brochure detailing specialty pharmacy access

CLICK HERE for prescribing information

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are ten LD deals that have been publicly confirmed subsequent to their approvals.

Onco360 to Distribute Vyloy 

Onco360 has been selected as a national pharmacy partner by Astellas for Vyloy (zolbetuximab-clzb), approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) positive, as determined by an FDA-approved test.

Onco360 to Distribute Gomekli

Onco360 has been selected as a national pharmacy partner by SpringWorks Therapeutics, Inc. for Gomekli (mirdametinib) for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1

Orsini to Distribute Attruby

Orsini has been selected by BridgeBio to distribute Attruby (acoramidis), an orally administered treatment for cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM). ATTRUBY is a near-complete (≥90%) stabilizer of transthyretin for the treatment of adults with ATTR-CM, to reduce cardiovascular death and cardiovascular-related hospitalization. 

Orsini to Distribute Kebilidi

Orsini announced that it has been chosen by PTC Therapeutics as the exclusive specialty pharmacy provider for the adeno-associated virus vector-based gene therapy Kebilidi (eladocagene exuparvovec-tneq). Kebilidi is approved for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency.

Orsini to Distribute Yorvipath

Orsini is partnering with Ascendis Pharma for the distribution of Yorvipath, a FDA approved parathyroid hormone analog (PTH1-34) indicated for the treatment of hypoparathyroidism in adults

PantherRx Rare to Distribute Attruby

PantherRx Rare has been selected by BridgeBio to distribute Attruby (acoramidis), an orally administered treatment for cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM). ATTRUBY is a near-complete (≥90%) stabilizer of transthyretin for the treatment of adults with ATTR-CM, to reduce cardiovascular death and cardiovascular-related hospitalization. 

Panther Rx Rare to Distribute Yorvipath

PantherRx Rare is partnering with Ascendis Pharma for the distribution of Yorvipath, a FDA approved parathyroid hormone analog (PTH1-34) indicated for the treatment of hypoparathyroidism in adults

Panther Rx Rare to Distribute Tryngolza

PantherRx Rare was selected by Ionis Pharmaceuticals, Inc. for the distribution of Tryngolza (olezarsen), the first and only treatment approved by the FDA as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

Panther Rx Rare to Distribute Crenessity

PantherRx Rare was selected by Neurocrine Biosciences, Inc. for the distribution of Crenessity (crinecerfont), an oral selective corticotropin-releasing factor type 1 (CRF1) receptor antagonist indicated to improve androgen control and enable a reduced glucocorticoid dose in patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).

AnovoRx Specialty Pharmacy to Distribute Increlex

AnovoRx has been named the exclusive distributor of Increlex (mecasermin injection) from Eton Pharmaceuticals (following the acquisition of Increlex from Ipsen S.A. Increlex is a biologic product used to treat pediatric patients 2 years of age and older who suffer from the severe primary insulin-like growth factor 1 deficiency (SPIGFD) a rare condition.