FDA Approved Drugs: March & April, 2022

Vivjoa (Oteseconazole)

Vivjoa, the first FDA-approved product for Mycovia, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to become the first FDA-approved therapy for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan, and Gedeon Richter Plc., a Hungary-based pharmaceutical company, to commercialize and manufacture oteseconazole in Europe, Russia, the Commonwealth of Independent States, Latin America and Australia. Mycovia also recognizes a tremendous potential for its oral fungal inhibitors and a growing need to treat a range of multi-drug resistant fungal pathogens.

Camzyos (Mavacamten)

Camzyosis the FIRST AND ONLY cardiac myosin inhibitor approved by the FDA indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. Camzyos is an allosteric and reversible inhibitor selective for cardiac myosin. Camzyos modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. Camzyos shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with Camzyos reduces dynamic LVOT obstruction and improves cardiac filling pressures.

Ztalmy (Ganaxolone)

Ztalmy, a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, is taken three times daily. Ztalmy is the FIRST ANDONLY FDA-approved treatment indicated specifically for seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients two years of age and older.

PLUVICTO™ (Lutetium Lu 177 vipivotide tetraxetan)

Pluvictois a PSMA targeted radioligand therapy that delivers DNA-breaking radiation directly to the PSMA positive bone, nodal and visceral metastases. It is the FIRST AND ONLY PSMA-targeted radioligand therapy for men with PSMA+ mCRPC who have been treated with androgen receptor pathway inhibitors and a taxane-based chemotherapy.

Cutaneous T-cell Lymphoma (CTCL): Market Size & Forecast

Cutaneous T-cell Lymphoma (CTCL): Market Size & Forecast

Disease Overview

Cutaneous T-cell Lymphoma (CTCL) is the most common type of skin lymphoma. CTCL is rare cancer that begins in white blood cells called T cells (T lymphocytes) and these the T cells develop abnormalities that make them attack the skin. It appears as an eczema-like skin rashes and can affect widespread parts of the body.

There are different types of Cutaneous T-cell Lymphoma (CTCL). Mycosis Fungoides and Sezary syndrome are the most frequent type of Cutaneous T-cell Lymphoma (CTCL). The other forms of cutaneous lymphoma include the CD30 positive lymphoproliferative disorders (CD30+ LPDs), subcutaneous panniculitis-like T-cell lymphoma, Primary cutaneous CD4+ small/medium pleomorphic T-cell lymphoma, Primary cutaneous gamma/delta T-cell lymphoma, Extranodal natural killer/T-cell lymphoma, nasal type, and others.

The World Health Organization (WHO) and the European Organization for Research and Treatment of Cancer (EORTC) Classification

Indolent Clinical Behavior Aggressive Clinical Behavior
Mycosis fungoides Sézary syndrome  
Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotopic T-cell lymphoma  
Primary cutaneous CD4+ small/medium pleomorphic T-Cell lymphoma   Primary cutaneous gamma/delta T-cell lymphoma  
CD30+ Lymphproliferative Disorders Primary cutaneous anaplastic large cell lymphomaLymphomatoid papulosis   Extranodal natural killer/T-cell lymphoma, nasal type  

Epidemiology

According to the CmaxInsight, the total incident cases of Cutaneous T-cell lymphoma (CTCL) were calculated to be around 9,000 in 2018 in 7MM including the United States, EU5 countries (the United Kingdom, France, Italy, Spain, and Germany) and Japan. The United States accounts for the highest incident cases of 3,430  in 2018 followed by EU5 countries, and Japan According to the National Organization for Rare Disorders (NORD), the Cutaneous T-cell lymphoma (CTCL) affects males twice as often as females. The majority of the CTCL cases are diagnosed between the age-group of 40 to 60 years. Further, it is expected that the incident cases of the CTCL would increase over the forecasted period.

Market Size

According to the Cmaxinsight, the market size of Cutaneous T-cell Lymphoma (CTCL) is growing at a CAGR of 5.54% for the forecasted period 2018-2028 in 7MM including the United States, EU5 countries (the United Kingdom, France, Italy, Spain, and Germany) and Japan. The United States accounts for the highest market share of around 40% in 2018 followed by EU5 countries, and Japan. The market is dominated by the availability of topical therapies, including corticosteroids, retinoids, different chemotherapy regimens, and others. The market is driven by rising incident cases, the expected launch of emerging therapies, technological advancement, and improving healthcare facilities.

Competitive Analysis

The market is dominated by the availability of the marketed drugs such as Istodax (Celgene Corporation), Poteligeo (Kyowa Hakko Kirin Co. Ltd), Valchlor/ Ledaga (Actelion), Uvadex (Mallinckrodt Pharmaceuticals), Targretin (Eisai Co., Ltd.), and Zolinza (Merck Sharp & Dohme Corp), and others. The expected launch of emerging therapies such as Quisinostat (Janssen), Remetinostat (Medivir AB), denileukin diftitox (Eisai Co., Ltd) and others shall have a positive impact on the market.

The companies are entering into the mergers, acquisitions, collaborations and other activities for increasing their market penetration. In January 2020, the Almirall had entered into an option agreement to acquire Bioniz Therapeutics and to establish a broad research agreement to further expand its innovative pipeline in medical dermatology. This collaboration would allow Almirall to executes its strategy to develop and expand its R&D pipeline with new treatment modalities with the objective to address highly underserved diseases within oncodermatology and immunodermatology.