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Botox, Keytruda Get FDA Approval For New Uses, BVXV Abuzz, First Droopy Eyelid Treatment Is Here

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Today's Daily Dose brings you news about Altimmune's AdCOVID vaccine, the growing list of approved indications for AbbVie's Botox, an update on Aldeyra's Dry Eye disease drug candidate Reproxalap and FDA approval of Merck's Keytruda for yet another indication.

Read on…

1. FDA Approves Expanded Use of AbbVie's Botox

The FDA has approved the expanded use of BOTOX for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.

Last October, BOTOX received the FDA nod in the indication of lower limb spasticity in pediatric patients, excluding those with cerebral palsy.

BOTOX, developed by Allergan, an AbbVie (ABBV) company, received its first FDA approval in 1989 for two rare eye muscle disorders - blepharospasm and strabismus in adults. Since then, it has received approval for a number of therapeutic indications, including Chronic Migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition, cervical dystonia, spasticity, and severe underarm sweating (axillary hyperhidrosis).

In 2019, BOTOX recorded annual sales of $3.79 billion - with therapeutic indications accounting for $2.13 billion and cosmetic sales registering $1.66 billion.

ABBV closed Thursday's trading at $97.94, down 1.35%.

2. Aldeyra To Initiate New Trials For Dry Eye Disease Drug Candidate

Shares of Aldeyra Therapeutics Inc. (ALDX) jumped more than 19 percent on Thursday as the Company continues to make progress with its Dry Eye disease drug candidate Reproxalap.

Aldeyra said that it intends to initiate two clinical trials to assess the activity of Reproxalap in reducing tear levels of RASP (reactive aldehyde species). The FDA has confirmed the use of RASP as an objective sign for the treatment of dry eye disease.

Top-line results from the first of the RASP trials are expected by the end of 2020, pending potential disruptions due to the COVID-19 pandemic. In addition, a safety trial in dry eye disease patients is expected to be initiated in the fourth quarter of 2020.

The Company expects to seek FDA approval of Reproxalap for dry eye disease in late 2021.

ALDX closed Thursday's trading at $5.20, up 19.27%.

3. Altimmune Gains Altitude

Altimmune Inc. (ALT) has teamed up with DynPort Vaccine Co. to coordinate U.S. Government funding efforts for AdCOVID.

DynPort Vaccine Co. develops vaccines and therapeutics for US Government customers.

AdCOVID, Altimmune's single-dose intranasal COVID-19 vaccine candidate, is under preclinical studies at the University of Alabama at Birmingham. The Company expects to begin the manufacturing of AdCOVID during this quarter, followed by a phase I clinical trial during the next quarter.

Shares of Altimmune have been rallying ever since its foray into COVID-19 drug and vaccine development space in February. The stock touched a new 52-week high of $24.65 in intraday trading on Thursday, before closing at $20.22, up 18.73%.

Related Reading

Altimmune's (ALT) Astounding Journey From $1 To $20 In Just Few Months

4. BiondVax Hits All-time High

Shares of BiondVax Pharmaceuticals Ltd. (BVXV) closed at an all-time high of $38.99, up 21.09% from the previous day's close.

BiondVax is an Israel-based biopharmaceutical company developing a universal flu vaccine. The Company's universal flu vaccine candidate, called M-001, is under a phase III trial across 83 sites and seven countries. The results from this phase III trial are expected by end of 2020.

BVXV has traded in a range of $5.20 to $41.64 in the last 1 year. The stock touched a high of $41.64 in intraday trading on Thursday, before closing at $38.99, up 21.09%.

5. Merck's Keytruda Scores Another Approval

Merck's (MRK) supplemental Biologics License Application for KEYTRUDA as monotherapy for second-line treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma has been granted priority review by the FDA - with a decision date set for October 30, 2020.

Classical Hodgkin lymphoma accounts for more than nine in 10 cases of Hodgkin lymphoma, which impacts approximately 7,400 patients a year in the U.S., according to the Company.

KEYTRUDA received accelerated approval in 2017 for treatment of adult and pediatric patients with Classical Hodgkin Lymphoma refractory to treatment, or who have relapsed after three or more prior lines of therapy.

Keytruda, one of Merck's blockbuster drugs, is approved for the treatment of Melanoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Head, and Neck Squamous Cell Cancer, Primary Mediastinal Large B-Cell Lymphoma, Urothelial Carcinoma, Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Renal Cell Carcinoma and Merkel Cell Carcinoma, among others.

The drug notched up sales of $3.3 billion in the first quarter of 2020, up 45% over the year-ago quarter.

MRK closed Thursday's trading at $76.69, down 1.58%.

6. Osmotica's Droopy Eyelid Treatment Gets FDA Approval

The FDA has approved Osmotica Pharmaceuticals plc's (OSMT) eye drop Upneeq for the treatment of acquired blepharoptosis.

Acquired blepharoptosis, also known as ptosis, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid.

Upneeq, formerly known as RVL-1201, is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting a-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller's muscle and elevate the upper eyelid.

Upneeq, which becomes the first and only FDA-approved pharmacologic treatment for acquired blepharoptosis, is expected to become commercially available next month to a selected group of ophthalmologists and optometrists.

OSMT closed Thursday's trading at $7.00, up 10.06%.

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